Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reach Surgical, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192566 | Reach and CQ'ENCE Circular Staplers | Reach Surgical, Inc. | 2019-10-17 | 29 | 0 |
| K120179 | REACH SURGICAL STAPLERS | Reach Surgical, Inc. | 2012-05-23 | 124 | 0 |
| K071023 | REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RC | Reach Surgical, Inc. | 2008-08-28 | 505 | 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