Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HXK — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
25 daysmedian FDA review time
57 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K890167 | HOLDER, NEEDLE | Dhason Brothers, Inc. | 1989-02-03 | 25 | 0 |
| K872989 | MICRINS NEEDLE HOLDER | Micrins Surgical, Inc. | 1987-08-21 | 21 | 0 |
| K860018 | FISCHER WIRE/PIN CLAMP | Buckman Co., Inc. | 1986-02-07 | 35 | 1 |
| K801594 | ACE FISCHER EXTERNAL FIXATION DEVICE | Ace Orthopedic Manufacturing Co. | 1980-09-09 | 57 | 0 |
| K772388 | CONVERSE-GILLIES NEEDLE HOLDER | Edward Weck, Inc. | 1978-01-20 | 24 | 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