Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HXY — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
48 daysmedian FDA review time
161 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923776 | BENDEREV DRILL GUIDE | Neimark Labs, Inc. | 1992-11-06 | 101 | 0 |
| K892904 | MITEK DRILL GUIDE | Mitek Surgical Products, Inc. | 1989-09-28 | 161 | 0 |
| K880264 | BONE SUTURE FIXATION DEVICE | Orthopedic Systems, Inc. | 1988-03-23 | 61 | 0 |
| K880381 | TELOS DISTAL TARGETING DEVICE | Austin Assoc. | 1988-03-15 | 48 | 0 |
| K880046 | HASTING FINGER FIXATOR INSTRUMENTS | Buckman Co., Inc. | 1988-02-16 | 41 | 0 |
| K831043 | ANDREWS REMOTE CHUCK DRILL | Orthopedic Systems, Inc. | 1983-04-28 | 28 | 0 |
| K770204 | CEMENT EXTRACTOR DRILL | Depuy, Inc. | 1977-02-08 | 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