Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgiquip, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
293 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935517 | SNAP STERNUM SAW | Surgiquip, Inc. | 1994-03-10 | 112 | 0 |
| K935357 | SNAP RECIPROCATING SAW | Surgiquip, Inc. | 1994-01-28 | 85 | 0 |
| K935322 | SNAP BONE REAMER | Surgiquip, Inc. | 1994-01-28 | 85 | 0 |
| K935516 | SNAP DRILL | Surgiquip, Inc. | 1994-01-27 | 70 | 0 |
| K931769 | SNAP OSCILLATING SAW | Surgiquip, Inc. | 1994-01-27 | 293 | 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