Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Getinge USA, 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) |
|---|---|---|---|---|---|
| K050664 | SPOR-TEST PA BIOLOGICAL INDICATOR KIT | Getinge USA, Inc. | 2005-04-07 | 23 | 0 |
| K032723 | BIOSIGN STEAM-24 BIOLOGICAL INDICATOR | Getinge USA, Inc. | 2003-10-01 | 28 | 0 |
| K031647 | BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGR | Getinge USA, Inc. | 2003-07-29 | 63 | 0 |
| K031259 | MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER | Getinge USA, Inc. | 2003-05-12 | 21 | 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