Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Enthermics Medical Systems, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132202 | DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CAB | Enthermics Medical Systems, Inc. | 2013-12-06 | 143 | 0 |
| K091336 | IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IV | Enthermics Medical Systems, Inc. | 2010-05-07 | 366 | 0 |
| K993797 | EC-7701 FLUID WARMING CABINET | Enthermics Medical Systems, Inc. | 2000-01-20 | 72 | 0 |
| K963731 | TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT | Enthermics Medical Systems, Inc. | 1997-04-22 | 217 | 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