Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HTW · Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
193 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151661 | Renovo Life Hard Carbon Coated Drill Bit | Renovo Life, LLC | 2016-01-15 | 210 | 0 |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | Hand Biomechanics Lab, Inc. | 1994-12-22 | 184 | 0 |
| K930339 | REAMER BIT | Neoligaments, Ltd. | 1993-08-06 | 193 | 0 |
| K915692 | CANNULATED DRILL BIT | W. L. Gore & Associates, Inc. | 1992-01-16 | 24 | 0 |
| K892903 | MITEK ANCHOR DRILL | Mitek Surgical Products, Inc. | 1989-10-06 | 169 | 0 |
| K870217 | FEMORAL CEMENT REMOVAL INSTRUMENTS | Kenneth J. Hoek, M.D., Inc. | 1987-02-06 | 16 | 0 |
| K863147 | GLENOID DRILL | Bowen & Company, Inc. | 1986-09-05 | 21 | 0 |
| K841629 | DRILL BIT | Plastafil, Inc. | 1984-08-27 | 130 | 0 |
| K834229 | BONE PLUGGING TOOL | Standard Surgical | 1984-01-10 | 35 | 0 |
| K831712 | SURGICAL DRILL BITS | Medical Specialists IN Packaging | 1983-07-07 | 41 | 0 |
| K820226 | UNIVERSALL DRILL GUIDE | Ortho Pared Instruments, Inc. | 1982-02-04 | 8 | 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