Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HXC — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
31 daysmedian FDA review time
63 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180092 | Intellitorq | Gauthier Biomedical, Inc. | 2018-03-08 | 55 | 0 |
| K874359 | ADJUSTABLE WRENCHES | Med-Tool, Inc. | 1987-11-23 | 31 | 0 |
| K874358 | COMBINATION WRENCHES | Med-Tool, Inc. | 1987-11-23 | 31 | 0 |
| K870053 | TORQUEDRIVER WRENCH | Jerome Medical | 1987-03-11 | 63 | 0 |
| K813067 | SPINAL WRENCH | Twin City Surgical, Inc. | 1981-11-24 | 25 | 0 |
| K791073 | WRENCH | Truth, Inc. | 1979-06-20 | 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