Medical device manufacturer
Welch Allyn Inc
Welch Allyn Inc holds 112 FDA 510(k) clearances across 47 product codes. Median elapsed review time is 71 days. openFDA lists 17 recall records naming the company. FDA publishes it under 5 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 112
- Product codes
- 47
- Median review
- 71 days
- Recall records
- 17
How does FDA spell Welch Allyn Inc?
FDA publishes this company under 5 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| WELCH ALLYN, INC. | device/registrationlisting | normalised |
| Welch Allyn | device/510k | normalised |
| Welch Allyn Inc | device/recall | normalised |
| Welch Allyn Inc | device/enforcement | normalised |
| Welch Allyn, Inc. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Welch Allyn Inc file in?
47 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 12 | 90 days | |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 12 | 85 days | |
| ERA | Otoscope | 9 | 14 days | |
| KZF | Device, Medical Examination, Ac Powered | 6 | 94 days | |
| HLI | Ophthalmoscope, Ac-Powered | 5 | 81 days | |
| BZG | Spirometer, Diagnostic | 4 | 73 days | |
| DPS | Electrocardiograph | 4 | 34 days | |
| DXQ | Blood Pressure Cuff | 4 | 115 days | |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | 4 | 25 days | |
| DQA | Oximeter | 3 | 91 days | |
| HIB | Speculum, Vaginal, Nonmetal | 3 | 43 days | |
| DSI | Detector And Alarm, Arrhythmia | 2 | 27 days | |
| FCW | Light Source, Fiberoptic, Routine | 2 | 37 days | |
| FER | Anoscope And Accessories | 2 | 14 days | |
| FSR | Light, Headband, Surgical | 2 | 87 days | |
| GCT | Light Source, Endoscope, Xenon Arc | 2 | 32 days | |
| HEX | Colposcope (And Colpomicroscope) | 2 | 91 days | |
| HKI | Camera, Ophthalmic, Ac-Powered | 2 | 128 days | |
| KAI | Mirror, Ent | 2 | 8 days | |
| CCW | Laryngoscope, Rigid | 1 | 8 days | |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 238 days | |
| DSK | Computer, Blood-Pressure | 1 | 182 days | |
| EIA | Unit, Operative Dental | 1 | 83 days | |
| EMA | Cement, Dental | 1 | 15 days | |
| EQH | Source, Carrier, Fiberoptic Light | 1 | 73 days |
Showing the 25 they file in most, of 47.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Welch Allyn Inc had a recall?
openFDA lists 17 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-2482-2021Class IIOpen, ClassifiedFLL
If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient
Z-1672-2021Class IITerminatedDXN
Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Z-1673-2021Class IITerminatedDXN
Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Z-1777-2017Class IITerminatedDXN
A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. This potential defect resides with the device, not the battery. The over-voltage condition can result in high NiMH battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components.
Z-0169-2016Class IITerminatedHIB
The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. This may result in a shattered lamp bulb and a potential electric shock hazard.
Showing the 5 most recently initiated of 17.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Welch Allyn Inc cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K243598 | Welch Allyn Connex® 360 (Multiple) | — | 234 | |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | MWI | 217 | |
| K223381 | iExaminer System with Panoptic Plus | HKI | 128 | |
| K212473 | Welch Allyn Connex Central Station | MWI | 448 | |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | BZG | 146 | |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System | NFJ | 90 | |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor | MHX | 28 | |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | MWI | 116 | |
| K141582 | CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION | DPS | 28 | |
| K132807 | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) | MWI | 144 |
Source: openFDA device/510k · retrieved
Where is Welch Allyn Inc registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Welch Allyn Inc files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.