Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
IPQ · 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) |
|---|---|---|---|---|---|
| K904934 | AUTOMASTER | Team Mfg., Inc. | 1991-05-21 | 201 | 0 |
| K910072 | SURE GRIP, HAND CONTROLS MODEL SG-1 | Howell Ventures , Ltd. | 1991-01-23 | 14 | 0 |
| K900416 | HAND CONTROLS, MODEL 3700 AND 3500 SERIES | Mobility Products & Design | 1990-05-30 | 120 | 0 |
| K884899 | DADC '500' DRIVING CONTROL | Driving Aids Development Corp. | 1989-02-10 | 74 | 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