Welch Allyn, Inc.: FDA clearances and approvals
Welch Allyn, Inc. has 112 FDA 510(k) clearances (first 1977, latest 2025), across 48 product codes in 10 review panels. Median 510(k) review time: 72 days. Since 2017 its median was 146 days, against 158 days for all cleared 510(k)s in the same product codes. openFDA lists 17 product recalls by a recalling firm named Welch Allyn, Inc. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 6 | 70 |
| 2013 | 2 | 52 |
| 2014 | 3 | 116 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 28 |
| 2018 | 1 | 90 |
| 2019 | 1 | 146 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 448 |
| 2023 | 1 | 128 |
| 2024 | 1 | 217 |
| 2025 | 1 | 234 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Welch Allyn, Inc.'s cleared 510(k)s took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 158 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 12 | 12 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 12 | 12 |
| ERA | Otoscope | 9 | 9 |
| KZF | Device, Medical Examination, Ac Powered | 6 | 6 |
| HLI | Ophthalmoscope, Ac-Powered | 5 | 5 |
| BZG | Spirometer, Diagnostic | 4 | 4 |
| DPS | Electrocardiograph | 4 | 4 |
| DXQ | Blood Pressure Cuff | 4 | 4 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | 4 | 4 |
| DQA | Oximeter | 3 | 3 |
Plus 38 more product codes.
Review panels
- Cardiovascular (38)
- Gastroenterology and Urology (16)
- Ophthalmic (15)
- Ear, Nose and Throat (14)
- General Hospital (9)
- Anesthesiology (8)
- Obstetrics and Gynecology (6)
- Dental (2)
- Radiology (1)
- General and Plastic Surgery (1)
Most recent Welch Allyn, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243598 | Welch Allyn Connex® 360 (Multiple) | — | 2025-07-13 | 234 |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | MWI | 2024-12-20 | 217 |
| K223381 | iExaminer System with Panoptic Plus | HKI | 2023-03-15 | 128 |
| K212473 | Welch Allyn Connex Central Station | MWI | 2022-10-28 | 448 |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | BZG | 2019-09-10 | 146 |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System | NFJ | 2018-07-16 | 90 |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor | MHX | 2017-06-30 | 28 |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | MWI | 2014-12-19 | 116 |
| K141582 | CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION | DPS | 2014-07-11 | 28 |
| K132807 | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) | MWI | 2014-01-31 | 144 |
102 earlier clearances. See the full list in Caduvo.
Recalls
17 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2021-07-20.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Welch Allyn, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00682526: Pre-Hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-Held Device (Completed, started 2003-06)
Frequently asked questions
How many FDA 510(k) clearances does Welch Allyn, Inc. have?
Welch Allyn, Inc. has 112 FDA 510(k) clearances (first 1977, latest 2025), across 48 product codes in 10 review panels.
How long does FDA take to clear Welch Allyn, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Welch Allyn, Inc.'s cleared 510(k)s is 72 days. Since 2017: 146 days, versus 158 days for all cleared 510(k)s in the same product codes.
What devices does Welch Allyn, Inc. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 12); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 12); ERA (Otoscope, 9).
Has Welch Allyn, Inc. had device recalls?
openFDA lists 17 product recalls in 7 recall events by a recalling firm whose name matches Welch Allyn, Inc; the most recent began 2021-07-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 112 Welch Allyn, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Welch Allyn, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.