Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micromedical Industries, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
1079 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013311 | MODIFICATION TO: POCKETVIEW ECG SOFTWARE | Micromedical Industries, Ltd. | 2002-01-03 | 91 | 0 |
| K012540 | BLY-501 ADAPTOR | Micromedical Industries, Ltd. | 2001-09-26 | 50 | 0 |
| K990266 | MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE | Micromedical Industries, Ltd. | 1999-02-02 | 5 | 1 |
| K922528 | CMS SYSTEM | Micromedical Industries, Ltd. | 1995-05-12 | 1079 | 0 |
| K915627 | PACEVIEW | Micromedical Industries, Ltd. | 1992-03-27 | 109 | 0 |
| K915624 | MODIFIED BIOLOG | Micromedical Industries, Ltd. | 1992-03-27 | 113 | 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