Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Benson Medical Instruments Co. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
266 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123896 | CCS-200 SPIROMETER | Benson Medical Instruments Co. | 2013-09-10 | 266 | 0 |
| K982441 | CCA-220 | Benson Medical Instruments Co. | 1998-10-09 | 87 | 0 |
| K981439 | CCA-200 | Benson Medical Instruments Co. | 1998-06-15 | 55 | 0 |
| K963681 | CCA-100 (MODIFIED) | Benson Medical Instruments Co. | 1996-10-08 | 89 | 0 |
| K924652 | BENSON CCA100 | Benson Medical Instruments Co. | 1993-04-09 | 206 | 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