Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micromedical Devices, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
231 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043287 | PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 | Micromedical Devices, Inc. | 2004-12-10 | 11 | 0 |
| K936195 | LAPAROSCOPES | Micromedical Devices, Inc. | 1994-08-17 | 231 | 0 |
| K936155 | ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA | Micromedical Devices, Inc. | 1994-04-11 | 105 | 0 |
| K936097 | VIDEO CAMERAS, ENCOSCOPIC AND SURGICAL | Micromedical Devices, Inc. | 1994-03-31 | 99 | 0 |
| K936086 | STERILE VIDEO CAMERA COVER AND DRAPE | Micromedical Devices, Inc. | 1994-03-17 | 86 | 0 |
| K850791 | MDI 2000 - PULSE GENERATOR | Micromedical Devices, Inc. | 1985-06-19 | 113 | 0 |
| K834262 | TRANS-PACE | Micromedical Devices, Inc. | 1984-02-04 | 58 | 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