Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomedical Devices, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
441 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955439 | THE REEL THING (MODIFICATION) | Biomedical Devices, Inc. | 1995-12-26 | 43 | 0 |
| K931847 | BIO-PREP CEMENT RESTRICTOR | Biomedical Devices, Inc. | 1994-06-28 | 441 | 7 |
| K931846 | BIO-PREP | Biomedical Devices, Inc. | 1994-01-21 | 283 | 0 |
| K925982 | BMD AIR/OXYGEN BLENDER | Biomedical Devices, Inc. | 1993-10-07 | 316 | 0 |
| K903533 | STERI-SHIELD | Biomedical Devices, Inc. | 1990-10-19 | 74 | 0 |
| K902677 | STERI-SHIELD | Biomedical Devices, Inc. | 1990-08-17 | 60 | 0 |
| K830605 | PUMP PALL AMBULATORY INSULIN INFUSION | Biomedical Devices, Inc. | 1983-03-31 | 34 | 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