Micromedical Industries, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Micromedical Industries, Ltd.” (first 1992, latest 2002), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 100 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DPS | Electrocardiograph | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| KRB | Probe, Thermodilution | 1 | 1 |
| LOS | 1 | 1 | |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Micromedical Industries, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013311 | MODIFICATION TO: POCKETVIEW ECG SOFTWARE | MHX | 2002-01-03 | 91 |
| K012540 | BLY-501 ADAPTOR | DPS | 2001-09-26 | 50 |
| K990266 | MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE | LOS | 1999-02-02 | 5 |
| K922528 | CMS SYSTEM | DQK | 1995-05-12 | 1079 |
| K915627 | PACEVIEW | KRB | 1992-03-27 | 109 |
| K915624 | MODIFIED BIOLOG | DRT | 1992-03-27 | 113 |
Recalls
openFDA lists no recalls under a recalling firm named Micromedical Industries, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Micromedical, Inc. (7 510(k)s)
- Micromedical Devices, Inc. (7 510(k)s)
- Micromedical Technologies, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Micromedical Industries, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Micromedical Industries, Ltd.” (first 1992, latest 2002), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Micromedical Industries, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micromedical Industries, Ltd. is 100 days.
Which FDA product codes appear under Micromedical Industries, Ltd.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 1); DQK (Computer, Diagnostic, Programmable, 1); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1).
Next steps
- See all 6 Micromedical Industries, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Micromedical Industries, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.