Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osborn Group, 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) |
|---|---|---|---|---|---|
| K002156 | APPRAISE URINE MICROALBUMIN COLLECTION KIT | Osborn Group, Inc. | 2000-12-19 | 155 | 0 |
| K993787 | APPRAISE-CARDIO SAMPLE COLLECTION KIT | Osborn Group, Inc. | 2000-04-14 | 157 | 3 |
| K990899 | HEMOCHEK-A1C SAMPLE COLLECTION KIT | Osborn Group, Inc. | 1999-12-21 | 278 | 34 |
| K991800 | HEMOCHEK URINE COLLECTION KIT | Osborn Group, Inc. | 1999-09-24 | 121 | 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