Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Device Services — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
87 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022753 | REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/W | Medical Device Services | 2002-11-14 | 87 | 0 |
| K022751 | REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS | Medical Device Services | 2002-11-04 | 77 | 0 |
| K022743 | REPROCESSED DISPOSABLE TROCARS | Medical Device Services | 2002-10-09 | 51 | 0 |
| K022748 | REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS | Medical Device Services | 2002-10-09 | 51 | 0 |
| K022744 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Medical Device Services | 2002-09-18 | 30 | 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