Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FYI · 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) |
|---|---|---|---|---|---|
| K871073 | OMEGA BIVALVE NASAL SPLINTS | Omega Silicone, Inc. | 1987-05-11 | 54 | 0 |
| K821178 | ETHICON EXTERNAL FIXATION WIRE | ETHICON, Inc. | 1983-06-11 | 410 | 0 |
| K801072 | STRAITH NASAL SPLINT | Surgical Technology Laboratories, Inc. | 1980-06-17 | 42 | 0 |
| K792106 | CONPHAR O.R. HEAD COVER-STERILE | Conphar, Inc. | 1979-11-05 | 11 | 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