Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HAD · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062413 | AESCULAP PNEUMATIC KERRISON | Aesculap, Inc. | 2006-11-21 | 96 | 0 |
| K022907 | ANSPACH POWERED KERRISON SYSTEM (PKS) | The Anspach Effort, Inc. | 2002-10-21 | 48 | 0 |
| K911637 | STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD | Personal Products Co. | 1991-08-02 | 113 | 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