Micromedical Devices, Inc.: FDA clearances and approvals
Micromedical Devices, Inc. has 7 FDA 510(k) clearances (first 1984, latest 2004), across 5 product codes in 4 review panels. Median 510(k) review time: 99 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
Review panels
Most recent Micromedical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043287 | PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 | IYO | 2004-12-10 | 11 |
| K936195 | LAPAROSCOPES | GCJ | 1994-08-17 | 231 |
| K936155 | ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA | HIF | 1994-04-11 | 105 |
| K936097 | VIDEO CAMERAS, ENCOSCOPIC AND SURGICAL | GCJ | 1994-03-31 | 99 |
| K936086 | STERILE VIDEO CAMERA COVER AND DRAPE | KXK | 1994-03-17 | 86 |
| K850791 | MDI 2000 - PULSE GENERATOR | DRO | 1985-06-19 | 113 |
| K834262 | TRANS-PACE | DRO | 1984-02-04 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Micromedical Devices, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Micromedical Devices, Inc. have?
Micromedical Devices, Inc. has 7 FDA 510(k) clearances (first 1984, latest 2004), across 5 product codes in 4 review panels.
How long does FDA take to clear Micromedical Devices, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Micromedical Devices, Inc.'s cleared 510(k)s is 99 days.
What devices does Micromedical Devices, Inc. make?
Its most frequent FDA product codes are DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 2); GCJ (Laparoscope, General & Plastic Surgery, 2); HIF (Insufflator, Laparoscopic, 1).
Has Micromedical Devices, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Micromedical Devices, Inc. Related entities may recall under other names.
Next steps
- See all 7 Micromedical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRO, Micromedical Devices, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.