Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FGS · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933604 | QB II BLUNT DISSECTOR | Joyce M. Shotwell, M.D. | 1993-09-23 | 58 | 0 |
| K931854 | ENDOSCOPIC BLUNT DISSECTING INSTRUMENT | Mayaguez Medical Center | 1993-08-10 | 119 | 0 |
| K923818 | O.R. CONCEPTS' IRRIGATING KITTNER | O.R. Concepts, Inc. | 1993-04-07 | 251 | 0 |
| K822194 | ENDOSCOPIC SPONGE CARRIER | Kelleher Corp. | 1982-08-27 | 35 | 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