Connector, Airway (Extension)
FDA product code BZA · Class I (low risk) · 21 CFR 868.5810 · Anesthesiology
94510(k) clearances
0PMA approvals
22recalls
Manufacturers
- Airlife, Inc. 11
- Dhd Medical Products Div. Diemolding Corp. 8
- Intersurgical, Inc. 4
- Intertech/Ohio 3
- Prima, Inc. 3
- Dhd Diemolding Healthcare Div. 3
- B&B Medical Technologies, Inc. 2
- Polamedco, Inc. 2
- Hospitak, Inc. 2
- Intec Medical, Inc. 2
- Instrumentation Industries, Inc. 2
- Sontek Industries, Inc. 2
- Surgicot, Inc. 2
- Medicomp, Inc. 2
- Acutronic Medical Systems AG 2
- Todd Industries, Inc. 1
- Mallinckrodt Critical Care 1
- Advanced Medical Equipment, Inc. 1
- Sherwood Medical Co. 1
- Mergenet Medical 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K083702 | Trach-AssistBZA · Traditional | Mergenet Medical | 03/05/2009SE |
| K954383 | Sureloc Circuit ConnectorBZA · Traditional | Polamedco, Inc. | 12/22/1995SE |
| K954197 | Disposable Flex TubeBZA · Traditional | Engstrom Medical | 10/26/1995SE |
| K953786 | Unicor, Inc. Connectors & Airway ExtensionsBZA · Traditional | Unicor, Inc. | 09/19/1995SE |
| K952824 | Neo-Link, Disposable Neonatal Air Way ConnectorBZA · Traditional | Intertex Medical, Inc. | 07/20/1995SE |
| K951345 | Disposable Airway Connectors for Gas SamplingBZA · Traditional | Catheter Research, Inc. | 04/14/1995SE |
| K944532 | Prima, Inc. Ventilator HosesBZA · Traditional | Prima, Inc. | 12/02/1994SE |
| K944535 | Prima, Inc. Gas Sampling Lines and ConnectorsBZA · Traditional | Prima, Inc. | 11/29/1994SE |
| K944534 | Prima, Inc. Connectors and Airway ExtensionsBZA · Traditional | Prima, Inc. | 11/29/1994SE |
| K942392 | Airway Connector with Flex TubeBZA · Traditional | Mallinckrodt Medical | 08/22/1994SE |
| K941026 | Thayer Mask to Mouthpiece Adapter/ConnectorBZA · Traditional | Thayer Medical Corp. | 08/18/1994SE |
| K940793 | Double Trach Swivel ConnectorBZA · Traditional | Seven Harvest Intl. Import & Export | 07/01/1994SE |
| K940544 | Double Trach Seivel ConnectorBZA · Traditional | Fvtnks | 04/19/1994SE |
| K935821 | Double Trach Swivel ConnectorBZA · Traditional | Nutec, Inc. | 01/14/1994SE |
| K931800 | Mag Connectors and Airway ExtensionsBZA · Traditional | Mag, Inc. | 05/19/1993SE |
| K931345 | Connectors and Airway ExtensionsBZA · Traditional | Precision Med Products, Ltd. | 04/23/1993SE |
| K931216 | Connectors and Airway ExtensionsBZA · Traditional | Teknor Medical Products, Inc. | 04/23/1993SE |
| K931038 | Connectors and Airway ExtensionsBZA · Traditional | Med-Plastics Intl., Inc. | 04/08/1993SE |
| K931036 | Connectors and Airway ExtensionsBZA · Traditional | Life Shield Healthcare Products, Inc. | 04/08/1993SE |
| K925263 | Meridian Medical Systems Connectors & Airway ExtBZA · Traditional | Merit Medical Systems, Inc. | 02/02/1993SE |
| K922537 | DuralifeBZA · Traditional | Dhd Diemolding Healthcare Div. | 12/04/1992SE |
| K924225 | Oxygen Swivel Adapter (Plastic)BZA · Traditional | Linjorel Products, Inc. | 09/04/1992SE |
| K921512 | Entended Line Accessories & ConnectorsBZA · Traditional | Intersurgical, Inc. | 06/17/1992SE |
| K921511 | Catheter Mounts -- ModificationBZA · Traditional | Intersurgical, Inc. | 06/17/1992SE |
| K913726 | Duralife(Tm)BZA · Traditional | Dhd Diemolding Healthcare Div. | 02/07/1992SE |
| K913216 | Trach T AdapterBZA · Traditional | Specialty Packaging Producs, Inc. | 01/15/1992SE |
| K912652 | Flex-ElbowBZA · Traditional | Vital Signs, Inc. | 10/10/1991SE |
| K911425 | Accessories & Connectors, 22MM-15MM-8.5MMBZA · Traditional | Intersurgical, Inc. | 06/24/1991SE |
| K911421 | Catheter MountsBZA · Traditional | Intersurgical, Inc. | 06/24/1991SE |
| K911294 | Ultraset CatheterBZA · Traditional | Dhd Diemolding Healthcare Div. | 06/10/1991SE |
| K895549 | M.D.I. AdapterBZA · Traditional | Custom Connection Corp. | 11/21/1989SE |
| K895014 | Baxter Baffled Tee AdapterBZA · Traditional | Baxter Healthcare Corp | 10/30/1989SE |
| K894969 | AeroventBZA · Traditional | Monaghan Medical Corp. | 10/30/1989SE |
| K895388 | Shiley Elbow 15MM Swivel ConnectorBZA · Traditional | Shiley, Inc. | 10/27/1989SE |
| K895144 | Intertech Metered Dose ElbowBZA · Traditional | Intertech/Ohio | 10/19/1989SE |
| K884374 | E.T. PufferBZA · Traditional | Kalajian Ent. | 11/23/1988SE |
| K881849 | Bodai M.D.D. Adaptor(Tm)BZA · Traditional | B&B Medical Technologies, Inc. | 07/01/1988SE |
| K882203 | Neotech Universal AdapterBZA · Traditional | Neotech Products, Inc. | 06/17/1988SE |
| K881230 | Flex TubeBZA · Traditional | Intertech Resources, Inc. | 04/14/1988SE |
| K873696 | Bodai NEO2-SAFE(TM)BZA · Traditional | B&B Medical Technologies, Inc. | 04/14/1988SE |
| K880434 | Medicomp Straight Swivel AdaptorBZA · Traditional | Medicomp, Inc. | 03/31/1988SE |
| K873974 | Tilson Trach GuardBZA · Traditional | Beevers Mfg. & Supply, Inc. | 12/22/1987SE |
| K871737 | CK 7000 Series 5 in 1 Connector and Y-ConnectorBZA · Traditional | Currie Medical Specialties, Inc. | 06/22/1987SE |
| K864896 | Medicomp Inhalant Mask ElbowBZA · Traditional | Medicomp, Inc. | 02/20/1987SE |
| K865046 | Salter Labs Model #4005 Gas Sampling Tee and LineBZA · Traditional | Salter Labs | 01/15/1987SE |
| K862435 | Double Lumen E T AdaptorBZA · Traditional | Acutronic Medical Systems AG | 10/22/1986SE |
| K863318 | Aerosol-TBZA · Traditional | Southmedic, Inc. | 09/11/1986SE |
| K862433 | Uni-Jet ConnectorBZA · Traditional | Acutronic Medical Systems AG | 08/06/1986SE |
| K860838 | Inspiron Double Swivel Trach AdapterBZA · Traditional | Inspiron Corp. | 04/09/1986SE |
| K860650 | 90 Degree Elbow & Straight ConnectorBZA · Traditional | Intertech/Ohio | 03/28/1986SE |
| K861056 | Straight Adapt W/Temp Sensing Port/Closure PlugBZA · Traditional | Intertech/Ohio | 03/27/1986SE |
| K860885 | Straight Connectors, 15MM, 30MM & 19MMBZA · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/20/1986SE |
| K860882 | Disposable CatheterBZA · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/20/1986SE |
| K860878 | British Breathing Circuit SystemBZA · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/20/1986SE |
| K860888 | Connectors/Valve InsertBZA · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/19/1986SE |
| K860887 | T-Pieces ConnectorsBZA · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/19/1986SE |
| K860886 | Straight Connectors, 22MMBZA · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/19/1986SE |
| K860881 | Catheter Mounts & Elbows (Various Types)BZA · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/19/1986SE |
| K860352 | Spacelabs Airway Adapter Set Series, No. 369014BZA · Traditional | Spacelabs, Inc. | 03/19/1986SE |
| K853828 | FLS Med. Prod. Racine Type AdaptorBZA · Traditional | Fls Medical Products, Inc. | 10/29/1985SE |
| K850964 | Double-Swivel ConnectorBZA · Traditional | Sheridan Catheter Corp. | 05/14/1985SE |
| K850625 | Argyle 15MM Swivel ConnectorBZA · Traditional | Sherwood Medical Co. | 03/21/1985SE |
| K844656 | Ohmeda Double Swivel AdapterBZA · Traditional | Ohmeda Medical | 02/12/1985SE |
| K840015 | Swivel Adaptor W/Alarm PortBZA · Traditional | Portex, Inc. | 01/17/1984SE |
| K833373 | Bodia Bronch-Saf Double SwivelBZA · Traditional | Sontek Industries, Inc. | 11/03/1983SE |
| K833372 | Bodia Trach-Saf Double SwivelBZA · Traditional | Sontek Industries, Inc. | 11/03/1983SE |
| K813383 | Disposable Trach Swivel ConnectorBZA · Traditional | Intec. | 12/31/1981SE |
| K812977 | Respiratory Care MonitorBZA · Traditional | Advanced Medical Equipment, Inc. | 11/16/1981SE |
| K812067 | Inspiratory Force Pressure AdaptorBZA · Traditional | Airlife, Inc. | 08/12/1981SE |
| K812000 | Pediatric Double Swivel ConnectorBZA · Traditional | Mallinckrodt Critical Care | 08/03/1981SE |
| K811922 | 45DEGREES Swivel ElbowBZA · Traditional | Dhd Medical Products Div. Diemolding Corp. | 07/23/1981SE |
| K811890 | Disposable Trach T OxygenatorBZA · Traditional | Airlife, Inc. | 07/15/1981SE |
| K811708 | Universal Adapter System-U/AdapitBZA · Traditional | Airlife, Inc. | 07/01/1981SE |
| K810621 | Disposable 22MM. Flexible AdaptorBZA · Traditional | Intec Medical, Inc. | 04/17/1981SE |
| K810620 | Disposable Elbow AdaptorBZA · Traditional | Intec Medical, Inc. | 03/20/1981SE |
| K810361 | Connector AdaptersBZA · Traditional | Todd Industries, Inc. | 03/17/1981SE |
| K802663 | Blow-By-Set-Up Connector-AirwayBZA · Traditional | Airlife, Inc. | 11/12/1980SE |
| K791539 | Disposable 22MM AdaptorBZA · Traditional | Hospitak, Inc. | 09/07/1979SE |
| K791538 | Disposable Aerosol TBZA · Traditional | Hospitak, Inc. | 09/07/1979SE |
| K791532 | Sureloc External ConnectorBZA · Traditional | Polamedco, Inc. | 09/04/1979SE |
| K790888 | Trach T with One-Way ValvesBZA · Traditional | Airlife, Inc. | 06/27/1979SE |
| K790887 | Tee AdapterBZA · Traditional | Airlife, Inc. | 06/05/1979SE |
| K790156 | Trach T W/Drainage BagBZA · Traditional | Airlife, Inc. | 04/20/1979SE |
| K790157 | Trach T AdapterBZA · Traditional | Airlife, Inc. | 02/01/1979SE |
| K790155 | Ventilator Elbow W/Suction PortBZA · Traditional | Airlife, Inc. | 02/01/1979SE |
| K790149 | Mask Intulation AdaptorBZA · Traditional | Airlife, Inc. | 02/01/1979SE |
| K790148 | Cuff ConnectorBZA · Traditional | Airlife, Inc. | 02/01/1979SE |
| K781759 | RescalBZA · Traditional | Diemolding Corp. | 11/27/1978SE |
| K781395 | Disposable Aerosol T Briggs AdaptorBZA · Traditional | Inhal-O-Tech Medical Plastic | 08/31/1978SE |
| K770630 | Adapter, Universal, Be 105-6BZA · Traditional | Instrumentation Industries, Inc. | 05/23/1977SE |
| K770634 | Adapter Be 105-101 & 125-101BZA · Traditional | Instrumentation Industries, Inc. | 04/08/1977SE |
| K770587 | Ventilator Adaptor, #751BZA · Traditional | Surgicot, Inc. | 04/05/1977SE |
| K770585 | Aerosol T Adapter, #752BZA · Traditional | Surgicot, Inc. | 04/05/1977SE |
| K770052 | Vital-Lok Tracheal Swivel CouplingBZA · Traditional | V.F.P. Corp. | 01/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0593-2026 Class I | ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of…Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Draeger, Inc. | 11/10/2025Open, Classified |
| Z-0592-2026 Class I | ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of…Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Draeger, Inc. | 11/10/2025Open, Classified |
| Z-0591-2026 Class I | ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of…Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Draeger, Inc. | 11/10/2025Open, Classified |
| Z-0590-2026 Class I | ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of…Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Draeger, Inc. | 11/10/2025Open, Classified |
| Z-0263-2025 Class II | 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD…Due to connector within the circuit flex extender not meeting specifications resulting in a low connection… | Westmed, Inc. | 09/27/2024Open, Classified |
| Z-0144-2025 Class II | smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF…Uncertainty in the seal integrity of the sterile packaging. | Smiths Medical ASD Inc. | 07/18/2024Open, Classified |
| Z-1582-2023 Class II | DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code…DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate.… | Smiths Medical ASD Inc. | 04/05/2023Open, Classified |
| Z-1581-2023 Class II | DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code…DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate.… | Smiths Medical ASD Inc. | 04/05/2023Open, Classified |
| Z-1580-2023 Class II | DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991)…DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate.… | Smiths Medical ASD Inc. | 04/05/2023Open, Classified |
| Z-2795-2020 Class II | Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use…The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in… | Bioseal Corporation | 08/15/2019Terminated |
| Z-0787-2020 Class II | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF…The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak… | Intersurgical Inc | 08/07/2019Terminated |
| Z-0786-2020 Class II | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF…The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak… | Intersurgical Inc | 08/07/2019Terminated |
| Z-0785-2020 Class II | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway…The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak… | Intersurgical Inc | 08/07/2019Terminated |
| Z-0784-2020 Class II | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway…The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak… | Intersurgical Inc | 08/07/2019Terminated |
| Z-1403-2018 Class II | Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50…These one-way valves may disconnect at the joint between the two components that make up the device, which… | Teleflex Medical Europe Ltd | 03/27/2018Terminated |
| Z-1361-2015 Class II | Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems…Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel Connector… | King Systems Corp. | 02/17/2015Terminated |
| Z-0652-2010 | Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical…Products 1664 and 1665 are each one-way valves that offer low flow resistance, each in one, opposite… | Telefelx Medical | 12/02/2009Terminated |
| Z-1944-2009 | Hudson RICA Sheridan, EB Tube, Sher-I-Bronch, LS, 35FR, Nova Plus, 37FR, 39 FR, and 41…The tether attaching to the double swivel cap may partially or completely break at the attachment points… | Teleflex Medical | 07/31/2009Terminated |
| Z-1943-2009 | Hudson RICA Sheridan, Sher-I-Bronch Accessory Pack, Teleflex Medical, Research Triangle…The tether attaching to the double swivel cap may partially or completely break at the attachment points… | Teleflex Medical | 07/31/2009Terminated |
| Z-1942-2009 | Hudson RICA Sheridan, ET Tube, Sher-I-Bronch RS, 28FR, 35 FR, 37 FR, 39FR and 41 FR…The tether attaching to the double swivel cap may partially or completely break at the attachment points… | Teleflex Medical | 07/31/2009Terminated |
| Z-1941-2009 | Hudson RICA Sheridan, ET Tube, Sher-I-Bronch LS, 28FR, 35FR, 37FR, 39FR and 41FR…The tether attaching to the double swivel cap may partially or completely break at the attachment points… | Teleflex Medical | 07/31/2009Terminated |
| Z-1940-2009 | Hudson RICA Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC…The tether attaching to the double swivel cap may partially or completely break at the attachment points… | Teleflex Medical | 07/31/2009Terminated |