Welch Allyn, Inc.
Medical device manufacturer in Skaneateles Falls, NY.
112510(k) clearances
0PMA approvals
5recalls
Device types
- MWI Monitor, Physiological, Patient (Without… 12
- DXN System, Measurement, Blood-Pressure… 12
- ERA Otoscope 9
- KZF Device, Medical Examination, Ac Powered 6
- HLI Ophthalmoscope, Ac-Powered 5
- FAM Sigmoidoscope And Accessories, Flexible/Rigid 4
- DXQ Blood Pressure Cuff 4
- BZG Spirometer, Diagnostic 4
- DPS Electrocardiograph 4
- DQA Oximeter 3
- HIB Speculum, Vaginal, Nonmetal 3
- HKI Camera, Ophthalmic, Ac-Powered 2
- HEX Colposcope (And Colpomicroscope) 2
- DSI Detector And Alarm, Arrhythmia 2
- FCW Light Source, Fiberoptic, Routine 2
- FSR Light, Headband, Surgical 2
- FER Anoscope And Accessories 2
- KAI Mirror, Ent 2
- GCT Light Source, Endoscope, Xenon Arc 2
- GCP Endoscope, Ac-Powered And Accessories 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243598 | Welch Allyn Connex® 360 (Multiple) · Traditional | 07/13/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | 12/20/2024SE |
| K223381 | iExaminer System with Panoptic PlusHKI · Traditional | 03/15/2023SE |
| K212473 | Welch Allyn Connex Central StationMWI · Traditional | 10/28/2022SE |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionBZG · Traditional | 09/10/2019SE |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemNFJ · Traditional | 07/16/2018SE |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…MHX · Special | 06/30/2017SE |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI · Traditional | 12/19/2014SE |
| K141582 | CP150 Electrocardiograph with Spirometry OptionDPS · Special | 07/11/2014SE |
| K132807 | Monitoring Station, Connex(R) Central Station (CS)MWI · Special | 01/31/2014SE |
| K132808 | Vital Signs Monitor, Connex Vital Signs MonitorMWI · Special | 11/20/2013SE |
| K131573 | CP150 ElectrocardiographDPS · Special | 07/03/2013SE |
| K121405 | PanopticHKI · Traditional | 12/20/2012SE |
| K122058 | Flexiport EcocuffDXQ · Traditional | 11/05/2012SE |
| K121013 | Connex Vital Signs Monitor 6000 SeriesMWI · Special | 07/26/2012SE |
| K120774 | Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT…DSI · Special | 04/10/2012SE |
| K120743 | Speculum, Vaginal, NonmetalHIB · Special | 03/23/2012SE |
| K120343 | Connex WorkstationMWI · Special | 02/24/2012SE |
| K112687 | Connex(R) Vital Signs Monitor 6000 SeriesMWI · Special | 11/22/2011SE |
| K110516 | Connex Vital Signs Monitor 6000 SeriesMWI · Special | 06/01/2011SE |
| K101680 | Welch Allyn Spot Vital Signs Lxi Model 45000 SeriesDXN · Special | 07/09/2010SE |
| K101445 | Vital Signs Monitor-Vsm 6000 SeriesMWI · Abbreviated | 06/08/2010SE |
| K093907 | Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceDXN · Abbreviated | 04/14/2010SE |
| K082478 | Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62BZG · Abbreviated | 03/09/2009SE |
| K070060 | Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood…DXQ · Traditional | 12/18/2007SE |
| K072449 | CP100 & 200 12-LEAD Resting ElectrocardiographsDPS · Abbreviated | 11/29/2007SE |
| K071218 | Proxenon 350, Model 902XXFST · Traditional | 06/14/2007SE |
| K070964 | Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination SystemHIB · Special | 05/18/2007SE |
| K053381 | Welch Allyn Connex Vital Solutions SoftwareDQA · Abbreviated | 06/15/2006SE |
| K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)DSI · Abbreviated | 12/16/2005SE |
| K053027 | VSM Vital Signs Monitor, Model 53000 (VSM 300)MWI · Special | 11/22/2005SE |
| K052784 | Device Connectivity Software Developers Kit (SDK), Model 4500-900DXN · Abbreviated | 11/22/2005SE |
| K052158 | Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareBZG · Special | 09/08/2005SE |
| K050074 | 12-LEAD Resting Electrocardiograph, Models CP100 & CP200DPS · Abbreviated | 03/22/2005SE |
| K040479 | Pediatric Energy Reducer, Models AED-10 and AED-20MKJ · Traditional | 09/14/2004SE |
| K040490 | Welch Allyn Spot Ultra Vital Signs DeviceDXN · Abbreviated | 08/18/2004SE |
| K033870 | Image Management SystemHEX · Traditional | 03/12/2004SE |
| K031549 | Solid State Lamp [Led] HeadlightFSR · Abbreviated | 08/11/2003SE |
| K031548 | LED HeadlightFSR · Abbreviated | 08/11/2003SE |
| K030580 | Suretemp PlusFLL · Traditional | 05/06/2003SE |
| K024005 | Welch Allyn Vital Sign Monitor with MP506DXN · Special | 02/12/2003SE |
| K023495 | Welch Allyn Vitals Software Developers Kit (SDK)DXN · Special | 10/31/2002SE |
| K022084 | Atlas Monitor, Models 200,210,220DQA · Special | 09/26/2002SE |
| K022163 | Welch Allyn Spot Vital Sign Monitor with MP506DQA · Special | 09/17/2002SE |
| K021756 | Welch Allyn Abpm 6100DXN · Special | 06/27/2002SE |
| K012455 | Welch Allyn Durashock Blood Pressure SystemDXQ · Abbreviated | 08/17/2001SE |
| K010186 | Welch Allyn Impact Blood Pressure SystemDXN · Abbreviated | 06/08/2001SE |
| K001543 | BPC-3000 Personal Blood Pressure Communicator, Model 52520DXN · Traditional | 01/29/2001SE |
| K003376 | Welch Allyn 11800 OpthalmoscopeHLI · Abbreviated | 01/25/2001SE |
| K002530 | Welch Allyn Spot Check DeviceDXN · Abbreviated | 11/14/2000SE |
| K001265 | Welch Allyn Instrument Interface ModuleMWI · Traditional | 07/13/2000SE |
| K984033 | Atlas MonitorDRT · Traditional | 07/08/1999SE |
| K984215 | Welch Allyn Front-Line DocLLZ · Traditional | 02/11/1999SE |
| K981937 | Welch Allyn Reveal Intraoral Camera SystemEIA · Traditional | 08/24/1998SE |
| K980281 | Welch Allyn Xenon 300 Light SourceGCT · Traditional | 02/27/1998SE |
| K971734 | VG 200 Video GastroscopeFDS · Traditional | 07/29/1997SE |
| K971750 | Welch Allyn Phaco IlluminatorHQC · Traditional | 06/30/1997SE |
| K970382 | VS-100 Video SigmoidoscopeFAM · Traditional | 04/17/1997SE |
| K955635 | Video Colposcope/Vertical Rolling Base/Swing Arm StandHEX · Traditional | 05/07/1996SE |
| K954704 | VS-200 Video SigmoidoscopeFDF · Traditional | 03/07/1996SE |
| K955043 | Welch Allyn Bi-OtoscopeERA · Traditional | 11/14/1995SE |
| K952835 | Welch Allyn Video EpiscopeKZF · Traditional | 09/22/1995SE |
| K950429 | Video SigmoidoscopeFAM · Traditional | 08/01/1995SE |
| K952691 | Welch Allyn Premium Lightweight HeadlightFJC · Traditional | 07/31/1995SE |
| K952289 | Welch Allyn Fiber Optic HeadligntHPQ · Traditional | 07/14/1995SE |
| K952578 | Welch Ally OtoscopeERA · Traditional | 07/10/1995SE |
| K951210 | Welch Allyn Video OphthalmoscopeHLI · Traditional | 06/06/1995SE |
| K951647 | Welch Allyn Hi - Lux IlluminatorFCW · Traditional | 05/17/1995SE |
| K950787 | Welch Allyn OtoscopeERA · Traditional | 04/06/1995SE |
| K950461 | Welch Allyn OphthalmoscopeHLI · Traditional | 04/04/1995SE |
| K943916 | VideotoscopeERA · Traditional | 08/25/1994SE |
| K941272 | KleenspecHIB · Traditional | 08/02/1994SE |
| K940493 | Hand Aneroid SphygmomanometerDXQ · Traditional | 07/01/1994SE |
| K941723 | Welch Allyn Glaucoma DetectorHOO · Traditional | 06/06/1994SE |
| K940270 | LCI-100 and LCI-200 Welch Allyn Illumination and Imaging SystemGCT · Traditional | 04/20/1994SE |
| K934259 | Ac-Powered Medical Examination LightKZF · Traditional | 01/28/1994SE |
| K931946 | Welch Allyn EarcleanerKYZ · Traditional | 07/26/1993SE |
| K930023 | Model #12000 Binocular Inderect OphthalmoscopeHLI · Traditional | 06/21/1993SE |
| K925899 | Ambulatory Blood Pressure Monitor, Mdl# 5100-01DSK · Traditional | 05/21/1993SE |
| K921493 | LS100 Halogen Examination Light, Model No: 44100KZF · Traditional | 11/03/1992SE |
| K922095 | LX 150 Light SourceEQH · Traditional | 07/17/1992SE |
| K920103 | Episcope, Model 47300KZF · Traditional | 04/28/1992SE |
| K913230 | Unidirectional OccluderHOY · Traditional | 10/02/1991SE |
| K895253 | Pneumocheck W/Printer/Charger and AccessoriesBZG · Traditional | 11/02/1989SE |
| K893440 | Flex Sigmoidoscope Light Source Model #45150FFS · Traditional | 07/28/1989SE |
| K884218 | Audioscope 3 Model 23300 AccessoriesEWO · Traditional | 03/10/1989SE |
| K875194 | Kleenspec Disposable Face Shield, Model 57001FXX · Traditional | 01/22/1988SE |
| K861516 | Welch Allyn TympanometerETY · Traditional | 06/10/1986SE |
| K852574 | Welch Allyn Model 40000 Sphyg W/ 40030-35 Blad & CDXN · Traditional | 03/13/1986SE |
| K852949 | Welch Allyn #48100 Task Lite W/Accessories AS ListKZF · Traditional | 09/04/1985SE |
| K852951 | Welch Allyn Fiber Optic Cables Various ModelsFCW · Traditional | 08/27/1985SE |
| K831709 | Audioscope #23000 W/71123 Charging StandERA · Traditional | 06/30/1983SE |
| K830047 | Fiber Optic Laryngoscopes W/BatteryCCW · Traditional | 01/18/1983SE |
| K822125 | Model 57000 Naso-Conjunctiva Isol. Mask · Traditional | 08/27/1982SE |
| K810227 | Model #53110 Disposable AnoscopeFER · Traditional | 02/19/1981SE |
| K801247 | CCD Endoscope and AttachmentsGCP · Traditional | 07/28/1980SE |
| K790610 | Sigmoidoscope TiplessFAM · Traditional | 04/23/1979SE |
| K782142 | Illiminator, Model 265 NasalERA · Traditional | 01/26/1979SE |
| K781517 | Automatic Blood Pressure DeviceDXN · Traditional | 01/11/1979SE |
| K781029 | Otoscope, Diag. Models 20100 & 20200ERA · Traditional | 06/28/1978SE |
| K780628 | Halogen Exam. Lite #48400KZF · Traditional | 06/06/1978SE |
| K771864 | Wall Transformers 74710 & 74910GCW · Traditional | 11/22/1977SE |
| K771900 | 71110 Desk ChargerHLS · Traditional | 11/09/1977SE |
| K771481 | Tongue Blade HolderEMA · Traditional | 08/19/1977SE |
| K771181 | Vaginal Illuminator, Model 78570HDG · Traditional | 07/14/1977SE |
| K770906 | Anoscope, Optic, FiberFER · Traditional | 06/01/1977SE |
| K770768 | Ophthalmoscope, Model #11100HLI · Traditional | 05/06/1977SE |
| K770770 | Wall Charger, Model #79111ERA · Traditional | 04/29/1977SE |
| K770769 | Otoscope/Illuminator, Model #21100ERA · Traditional | 04/29/1977SE |
| K770291 | Sigmoidoscope, Disposable, Model #53125FAM · Traditional | 02/18/1977SE |
| K770054 | Mirror, Naso-PharynxKAI · Traditional | 01/18/1977SE |
| K770053 | Mirror, LaryngealKAI · Traditional | 01/18/1977SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2482-2021 Class II | Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of…If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there… | 07/20/2021Open, Classified |
| Z-1673-2021 Class II | ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models)…Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and… | 04/22/2021Terminated |
| Z-1672-2021 Class II | GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended…Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and… | 04/22/2021Terminated |
| Z-1777-2017 Class II | Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in…A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may… | 02/27/2017Terminated |
| Z-0169-2016 Class II | Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System…The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly… | 10/02/2015Terminated |