Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HXP · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
7 daysmedian FDA review time
86 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K872858 | WILLIAMS VERTEBRAL SPREADER | Ace Medical Co. | 1987-10-15 | 86 | 0 |
| K800730 | RETROGRADE KNIFE | Stainless Mfg., Inc. | 1980-04-08 | 7 | 0 |
| K800733 | DOUBLE-EDGE CURETTE | Stainless Mfg., Inc. | 1980-04-08 | 7 | 0 |
| K800732 | MENISCOTOME | Stainless Mfg., Inc. | 1980-04-08 | 7 | 0 |
| K800731 | MENISCAL SAW | Stainless Mfg., Inc. | 1980-04-08 | 7 | 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