Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EMM · 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) |
|---|---|---|---|---|---|
| K963897 | STERI-OSS SINUS AUGMENTATION KIT | Steri-Oss, Inc. | 1996-11-06 | 40 | 0 |
| K864775 | CHISEL (OSTEOTOME, GOUGE, ETC.) | New England Surgical Instrument Corp. | 1987-02-12 | 69 | 0 |
| K851714 | 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS | Artiberia | 1985-06-11 | 47 | 0 |
| K760959 | SURGICAL CHISEL | American Safety Equipment Corp. | 1976-11-15 | 14 | 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