Welch Allyn Protocol, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Welch Allyn Protocol, Inc.” (first 2001, latest 2007), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Baxter, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 2 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 1 |
Review panels
- Cardiovascular (6)
- Anesthesiology (1)
Most recent Welch Allyn Protocol, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070204 | LINK TO ACUITY CLINICIAN NOTIFIER | MSX | 2007-03-23 | 60 |
| K063419 | MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) | MWI | 2006-12-04 | 21 |
| K033378 | VITAL SIGNS MONITOR, PROPAQ LT | MWI | 2004-03-01 | 131 |
| K031740 | VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES | DQA | 2003-08-26 | 83 |
| K022453 | MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM | DSI | 2002-08-21 | 26 |
| K021681 | MICROPAQ, MODELS 402, 404 | DRT | 2002-07-23 | 62 |
| K012451 | PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 | DRT | 2001-08-20 | 19 |
Recalls
16 product recalls in 15 recall events; 0 initiated in the last five years. Most recent: 2013-11-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Welch Allyn, Inc. (112 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Welch Allyn Protocol, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Welch Allyn Protocol, Inc.” (first 2001, latest 2007), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Welch Allyn Protocol, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Welch Allyn Protocol, Inc. is 60 days.
Which FDA product codes appear under Welch Allyn Protocol, Inc.?
The most frequent FDA product codes under this applicant name are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 2); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 2); DQA (Oximeter, 1).
Next steps
- See all 7 Welch Allyn Protocol, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRT, Welch Allyn Protocol, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.