Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omni Therm, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
257 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961176 | OMNI COLD GEL PACKS | Omni Therm, Inc. | 1996-09-04 | 163 | 0 |
| K955788 | IMNI HOT PACKS | Omni Therm, Inc. | 1996-09-04 | 257 | 0 |
| K954877 | OMNI COLD GEL PACKS | Omni Therm, Inc. | 1996-02-13 | 112 | 0 |
| K936084 | OMNI WARM GEL PACKS | Omni Therm, Inc. | 1994-03-31 | 100 | 6 |
| K864853 | OMNI THERM TEMPERATURE MONITOR | Omni Therm, Inc. | 1987-02-04 | 55 | 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