Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HPM — 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) |
|---|---|---|---|---|---|
| K003305 | PEDIATRIC INGESTASCAN | Adams Electronics, Inc. | 2000-12-22 | 63 | 0 |
| K953277 | SHADOW MEDAL LOCATOR | Fatswith Intl., Inc. | 1996-04-01 | 263 | 0 |
| K911886 | PMT METAL LOCATOR, MODEL 3630-1 | Pmt Corp. | 1991-08-12 | 105 | 0 |
| K781892 | LOCATOR, FOREIGN BODY | Keeler Optical Products , Ltd. | 1978-12-04 | 26 | 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