Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
BRY · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
26 daysmedian FDA review time
82 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921710 | MOVIT DEVICE | John J. Navar, M.D. | 1992-06-29 | 82 | 0 |
| K912346 | MEDIKEEPER | Medikeeper, Inc. | 1991-07-30 | 63 | 0 |
| K901474 | ANESTHESIA WORKSTATION | Siemens Life Support Systems | 1990-04-10 | 14 | 0 |
| K871564 | ANESTHASSIST | Anestech, Inc. | 1987-05-18 | 26 | 0 |
| K821307 | ANESTHECACHE | Med-Life, Inc. | 1982-05-14 | 10 | 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