Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Westmed, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
281 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162343 | Westmed Gas Sampling Cannula with O2 delivery | Westmed, Inc. | 2016-12-14 | 114 | 0 |
| K143148 | Disposable Pressure Manometer (DPM) | Westmed, Inc. | 2015-08-11 | 281 | 0 |
| K133057 | VIBRALUNG ACOUSTICAL PERCUSSOR | Westmed, Inc. | 2014-05-23 | 238 | 0 |
| K121382 | WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] | Westmed, Inc. | 2012-12-06 | 212 | 0 |
| K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | Westmed, Inc. | 2008-07-15 | 12 | 7 |
| K072220 | PEDI CO2 EASY | Westmed, Inc. | 2007-08-23 | 13 | 0 |
| K070128 | CO2 EASY | Westmed, Inc. | 2007-02-15 | 30 | 0 |
| K953464 | WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK | Westmed, Inc. | 1995-09-18 | 56 | 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