Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
M.C. Johnson Co., Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953375 | NG SECURE | M.C. Johnson Co., Inc. | 1995-09-08 | 52 | 0 |
| K872525 | A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH | M.C. Johnson Co., Inc. | 1988-02-22 | 242 | 0 |
| K832702 | POCKET AID | M.C. Johnson Co., Inc. | 1983-11-17 | 98 | 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