Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DWG — 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) |
|---|---|---|---|---|---|
| K942823 | MAHE INSTRUMENTS | Mahe Intl., Inc. | 1994-12-05 | 174 | 0 |
| K932345 | TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE | Conmedcorp | 1994-04-12 | 333 | 0 |
| K931215 | HAND-TROL S | Aspen Labs | 1994-03-28 | 383 | 0 |
| K925708 | DISPOSABLE ELECTROSURGERY BALL ELECTRODE | Beacon Laboratories, Inc. | 1993-04-20 | 159 | 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