Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Welch Allyn Protocol, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
131 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070204 | LINK TO ACUITY CLINICIAN NOTIFIER | Welch Allyn Protocol, Inc. | 2007-03-23 | 60 | 0 |
| K063419 | MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) | Welch Allyn Protocol, Inc. | 2006-12-04 | 21 | 1 |
| K033378 | VITAL SIGNS MONITOR, PROPAQ LT | Welch Allyn Protocol, Inc. | 2004-03-01 | 131 | 3 |
| K031740 | VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES | Welch Allyn Protocol, Inc. | 2003-08-26 | 83 | 0 |
| K022453 | MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM | Welch Allyn Protocol, Inc. | 2002-08-21 | 26 | 1 |
| K021681 | MICROPAQ, MODELS 402, 404 | Welch Allyn Protocol, Inc. | 2002-07-23 | 62 | 0 |
| K012451 | PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 24 | Welch Allyn Protocol, Inc. | 2001-08-20 | 19 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda