Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med Labs, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960457 | ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C | Med Labs, Inc. | 1996-09-06 | 220 | 0 |
| K935981 | MLT-2 | Med Labs, Inc. | 1994-02-17 | 65 | 0 |
| K923819 | EEC-1 PACKAGE | Med Labs, Inc. | 1992-11-06 | 99 | 0 |
| K903652 | SCAN COM AND SCAN COM P (TENTATIVE) | Med Labs, Inc. | 1990-08-24 | 11 | 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