Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HTJ · 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) |
|---|---|---|---|---|---|
| K940480 | ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE | Acufex Microsurgical, Inc. | 1994-03-23 | 49 | 0 |
| K925335 | ACUFEX INTRA ARTICULAR MEASURING DEVICE | Acufex Microsurgical, Inc. | 1992-12-29 | 68 | 0 |
| K873191 | ACROMED INTERBODY DEPTH GAUGES | Buckman Co., Inc. | 1987-09-09 | 27 | 0 |
| K864426 | RAYLOR(TM) DEPTH GAUGE | Cedar Surgical, Inc. | 1986-11-26 | 16 | 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