Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Galemed Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
150 daysmedian FDA review time
359 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132679 | AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER | Galemed Corp. | 2014-04-18 | 233 | 0 |
| K133957 | DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE | Galemed Corp. | 2014-04-14 | 112 | 0 |
| K122627 | GIO DIGITAL PRESSURE GUAGES | Galemed Corp. | 2013-08-22 | 359 | 0 |
| K082092 | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VA | Galemed Corp. | 2008-10-15 | 83 | 0 |
| K072755 | GALEMED CPAP MASK | Galemed Corp. | 2007-11-16 | 50 | 0 |
| K022124 | GALEMED PEAK FLOW METER, MODELS 3751/3752 | Galemed Corp. | 2003-04-03 | 276 | 0 |
| K021742 | GALEMED NEB-EASY NEBULIZER | Galemed Corp. | 2002-10-25 | 150 | 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