Tubing, Fluid Delivery
FDA product code FPK · Class II (moderate risk) · 21 CFR 880.5440 · General Hospital
64510(k) clearances
0PMA approvals
26recalls
Manufacturers
- Churchill Corp. 3
- Clinical Connections, Inc. 3
- 3M Company 2
- Distronic Sterile Products, Inc. 2
- Medrad, Inc. 2
- Degania Silicone, Ltd. 2
- Medtronic Minimed 2
- Harvard Laboratories 2
- Quest Medical, Inc. 1
- Concept, Inc. 1
- Medrad, Inc. / Bayer Medical Care, Inc. 1
- Venusa , Ltd. 1
- Sea Medical Products, Inc. 1
- Terumo Medical Corp. 1
- Argon Medical Corp. 1
- Mor-Mac, Inc. 1
- Berman, Pcp & Consultants, Inc. 1
- Norton Performance Plastics Corp. 1
- Medical Disposables Intl., Inc. 1
- Abco Dealers, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131517 | Medrad Twist & Go High Pressure Connector TubingFPK · Special | Medrad, Inc. / Bayer Medical Care, Inc. | 08/02/2013SE |
| K063114 | Disposable Transfer Sets with and Without Swabbable Valves And/Or Check ValvesFPK · Abbreviated | Coeur, Inc. | 02/09/2007SE |
| K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 &…FPK · Traditional | Hospira, Inc. | 12/11/2006SE |
| K052431 | Medtronic Minimed Leapfrog II Infusion Set, Models MMT-801S1, MMT-801L1, MMT-801S2…FPK · Traditional | Medtronic Minimed | 11/29/2005SE |
| K041178 | Empower Transfer Set, (Cat. No. 7725)FPK · Traditional | E-Z-Em, Inc. | 07/16/2004SE |
| K031808 | Medrad Swabbable Valve Transfer SetFPK · Special | Medrad, Inc. | 07/11/2003SE |
| K022431 | Medrad Transfer SetFPK · Traditional | Medrad, Inc. | 09/05/2002SE |
| K965208 | Polyfin Extension Set, Models 126 and 128FPK · Traditional | Medtronic Minimed | 02/26/1997SE |
| K953864 | Silclear Tubing (Modification)FPK · Traditional | Degania Silicone , Ltd. | 11/06/1995SE |
| K950508 | Sysmex SF-3000FPK · Traditional | Sysmex Corp. | 11/03/1995SE |
| K952243 | Extension Set/I.V. SetFPK · Traditional | Coast Medical, Inc. | 07/26/1995SE |
| K952663 | 60 Micro Volume Extension Set W/.22 Micron Filter, 21 Extension Set W/1.2 Mivton Gilyrt…FPK · Traditional | Distronic Sterile Products, Inc. | 07/14/1995SE |
| K950861 | Reconstitution AccessoreisFPK · Traditional | Organon, Inc. | 05/26/1995SE |
| K933524 | Extention SetFPK · Traditional | Mediziv Medical Products 1987 , Ltd. | 05/23/1995SE |
| K950200 | IvidFPK · Traditional | Scott/Ross Designs, Inc. | 03/24/1995SE |
| K943992 | Silclear TubingFPK · Traditional | Degania Silicone , Ltd. | 03/16/1995SE |
| K943206 | Various TubingFPK · Traditional | Prn Services, Inc. | 03/09/1995SE |
| K945184 | Intravascular Administration SetFPK · Traditional | Distronic Sterile Products, Inc. | 02/08/1995SE |
| K941214 | Lifeshield Extension SetFPK · Traditional | Abbott Mfg., Inc. | 10/03/1994SE |
| K935642 | Evans Medical Extension SetsFPK · Traditional | Evans Medical, Inc. | 01/28/1994SE |
| K921450 | Non-Invasive TubingFPK · Traditional | Specialty Medical Sales, Inc. | 02/05/1993SE |
| K923972 | Ophthalmic Fluid Distribution SetsFPK · Traditional | Visitec Co. | 11/04/1992SE |
| K915560 | Lo-Profile Extension SetFPK · Traditional | Douglas Medical Products Corp. | 05/14/1992SE |
| K912103 | Lifeshield Extension SetFPK · Traditional | Abbott Laboratories | 12/13/1991SE |
| K910906 | Centurion Kleen-Needle System I.V. Extension SetsFPK · Traditional | Tri-State Hospital Supply Corp. | 04/01/1991SE |
| K891009 | Intravascular Administration Set Model 60040FPK · Traditional | 3M Company | 05/16/1989SE |
| K891005 | Intravascular Admini. Set Models 60030 & 60050FPK · Traditional | 3M Company | 05/11/1989SE |
| K883718 | Merit Hi-Flex(Tm)FPK · Traditional | Merit Medical Systems, Inc. | 01/30/1989SE |
| K884156 | Hyperbaric Intravenous Infusion Extension SetFPK · Traditional | Sechrist Industries, Inc. | 11/14/1988SE |
| K884370 | CMS IV Extension SetsFPK · Traditional | Churchill Medical Systems, Inc. | 11/07/1988SE |
| K875186 | IV Extension SetFPK · Traditional | Marquette Medical, Inc. | 02/16/1988SE |
| K873465 | Van Dellen Bacteria FilterFPK · Traditional | Van Dellen, Ltd. | 01/20/1988SE |
| K873852 | Infusion ManifoldFPK · Traditional | Advanced Surgical Products, Inc. | 11/23/1987SE |
| K874360 | Plastic Tubing ConnectorFPK · Traditional | American Medical Technology, Inc. | 11/17/1987SE |
| K871085 | Extension Tube Pump SetFPK · Traditional | Churchill Corp. | 06/15/1987SE |
| K871540 | Swivel Connectors #014452/#014453/#014459-120FPK · Traditional | Clinical Connections, Inc. | 04/30/1987SE |
| K870416 | LP Extension SetsFPK · Traditional | North Coast Medi-Tek | 04/06/1987SE |
| K870912 | T-Connectors 014500/014501/014502/014503-120FPK · Traditional | Clinical Connections, Inc. | 03/17/1987SE |
| K870326 | Various Luer and Tubing FittingsFPK · Traditional | Clinical Connections, Inc. | 02/10/1987SE |
| K864692 | Extension SetsFPK · Traditional | Salt Creek Medical Technologies | 12/18/1986SE |
| K864395 | Low Volume Extension SetFPK · Traditional | Panamedix, Inc. | 12/16/1986SE |
| K861626 | Churchill Extension TubeFPK · Traditional | Churchill Corp. | 06/02/1986SE |
| K854629 | Churchill-H Extension TubeFPK · Traditional | Churchill Corp. | 12/10/1985SE |
| K834164 | Spinal Needles & AccessoryFPK · Traditional | Elfa Trading Co. | 12/13/1983SE |
| K833659 | IV Extension SetFPK · Traditional | Dna Medical, Inc. | 11/29/1983SE |
| K833076 | C-Flex Medical Grade TubingFPK · Traditional | Concept, Inc. | 11/21/1983SE |
| K832758 | Red Color-Tinted TubingFPK · Traditional | Custom Medical, Inc. | 09/12/1983SE |
| K820527 | Anesthesia Extension TubesFPK · Traditional | David Simmonds Co., Inc. | 03/18/1982SE |
| K812981 | Fluven Sets (EXT-1, EXT-2, EXT-3, EXT-4)FPK · Traditional | Venusa , Ltd. | 11/06/1981SE |
| K811847 | Sea Medical Products Lo-VolFPK · Traditional | Sea Medical Products, Inc. | 07/13/1981SE |
| K810005 | Safeed Extension TubesFPK · Traditional | Terumo Medical Corp. | 02/05/1981SE |
| K800879 | Clear Plastic Connecting TubesFPK · Traditional | Harvard Laboratories | 06/17/1980SE |
| K800877 | Anesthesia Extension TubesFPK · Traditional | Harvard Laboratories | 06/17/1980SE |
| K800825 | Extension Set Quest Code #3000FPK · Traditional | Quest Medical, Inc. | 05/14/1980SE |
| K781087 | Medical Grade Silicone Elastomer TubingFPK · Traditional | Mcghan Medical Corp. | 11/22/1978SE |
| K780673 | Central Catheter KitFPK · Traditional | Argon Medical Corp. | 05/16/1978SE |
| K780396 | Nasal Gastric Tube RetainerFPK · Traditional | Mor-Mac, Inc. | 03/22/1978SE |
| K772119 | Time WatchFPK · Traditional | Akzona, Inc. | 11/14/1977SE |
| K771269 | Blood Collection Set Type HFPK · Traditional | Berman, Pcp & Consultants, Inc. | 09/12/1977SE |
| K771387 | Monitoring Lines & Fluid Admin.FPK · Traditional | Norton Performance Plastics Corp. | 08/22/1977SE |
| K770945 | Pouch, Tyvek-PolymylonFPK · Traditional | Medical Disposables Intl., Inc. | 06/29/1977SE |
| K770596 | ConnectorsFPK · Traditional | Abco Dealers, Inc. | 06/20/1977SE |
| K770174 | Luer-Lock Extension SetFPK · Traditional | American Viggo | 03/30/1977SE |
| K770108 | Tube Holding DeviceFPK · Traditional | Pharmaseal Div., Baxter Healthcare Corp. | 03/10/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2293-2025 Class II | High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/CHigh pressure tubing may relax over time causing it to partially separate from the connector resulting in a… | Merit Medical Systems, Inc. | 06/05/2025Open, Classified |
| Z-0111-2018 Class II | Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Medtronic Inc. | 09/10/2017Open, Classified |
| Z-1016-2017 Class II | Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended…Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin… | Hospira Inc. | 02/19/2013Terminated |
| Z-1672-2012 | Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly…Moog Medical Device Group became aware on March 23, 2011 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1671-2012 | Non-DEHP Microbore Admin Set with Non-Vented Spike and Needleless Injection Port…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1670-2012 | Non-DEHP Admin Set Non-Vented Spike and 1.2 Micron Filter ASV Packaged Assembly, product…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1669-2012 | Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged, product code:…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1668-2012 | Non-DEHP Epidural Admin Set with 0.2 Micron Filter Non-Vented Bag Spike ASV Packaged…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1667-2012 | Non-DEHP Epidural Yellow Striped Tubing Admin Set with Vented Vial Spike and 0.2 Micron…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1666-2012 | Non-DEHP Microbore Admin Set with Female Male Luer Locks and Y-Site with Check Valve…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1665-2012 | Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1664-2012 | Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1663-2012 | Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1662-2012 | Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1661-2012 | Epidural Admin Set with Non-Vented Bag Spike and 0.2 Micron Filter Package Assembly…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1660-2012 | Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1659-2012 | Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly, product…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | MOOG Medical Devices Group | 05/18/2012Terminated |
| Z-1798-2008 | Contour Genesis Inf/IR Tubing; Part Number CG-UT; distributed by Mentor Texas, LP…During packaging integrity validation, it was found that various product packages could fail, compromising… | Mentor Texas, Inc | 04/21/2008Terminated |
| Z-1797-2008 | Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor…During packaging integrity validation, it was found that various product packages could fail, compromising… | Mentor Texas, Inc | 04/21/2008Terminated |
| Z-1796-2008 | Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; distributed…During packaging integrity validation, it was found that various product packages could fail, compromising… | Mentor Texas, Inc | 04/21/2008Terminated |
| Z-1795-2008 | Irrigation Tubing, 25'; Part Number 5120-25; distributed by Mentor Texas, LP, Irving, TX…During packaging integrity validation, it was found that various product packages could fail, compromising… | Mentor Texas, Inc | 04/21/2008Terminated |
| Z-1794-2008 | Y Tubing Set, 9'; 10/box; Part Number LAM-Y; distributed by Mentor Texas, LP, Irving, TX…During packaging integrity validation, it was found that various product packages could fail, compromising… | Mentor Texas, Inc | 04/21/2008Terminated |
| Z-1793-2008 | Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; distributed by Mentor Texas, LP…During packaging integrity validation, it was found that various product packages could fail, compromising… | Mentor Texas, Inc | 04/21/2008Terminated |
| Z-1792-2008 | Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving…During packaging integrity validation, it was found that various product packages could fail, compromising… | Mentor Texas, Inc | 04/21/2008Terminated |
| Z-1791-2008 | Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving…During packaging integrity validation, it was found that various product packages could fail, compromising… | Mentor Texas, Inc | 04/21/2008Terminated |
| Z-1790-2008 | Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558; distributed by Mentor Texas, LP…During packaging integrity validation, it was found that various product packages could fail, compromising… | Mentor Texas, Inc | 04/21/2008Terminated |