Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thermogenesis Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081345 | AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-51 | Thermogenesis Corp. | 2008-07-10 | 57 | 0 |
| K071126 | CRYOSEAL FS APPLICATOR SYSTEM | Thermogenesis Corp. | 2007-08-16 | 115 | 0 |
| K955282 | THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS | Thermogenesis Corp. | 1996-05-06 | 172 | 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