Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HTT · 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) |
|---|---|---|---|---|---|
| K862529 | HALL STERILE BUR | Hall Surgical, Division of Zimmer, Inc. | 1986-07-15 | 13 | 0 |
| K821695 | MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER | Micro-Aire Surgical Instruments, Inc. | 1982-07-20 | 42 | 0 |
| K802598 | CARBIDE CUTTING INSTRUMENT/INTRAARTICU | The Anspach Effort, Inc. | 1980-11-19 | 29 | 13 |
| K760236 | BUR, SURGICAL CARBIDE | Cutter Laboratories, Inc. | 1976-07-26 | 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