Micromedical Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Micromedical Technologies, Inc.” (first 1987, latest 1997), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 200 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 |
|---|---|---|---|
| GWN | Nystagmograph | 3 | 3 |
| LXV | Apparatus, Vestibular Analysis | 2 | 2 |
Review panels
- Neurology (3)
- Ear, Nose and Throat (2)
Most recent Micromedical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964646 | VIDEO EYE TRAKKER | GWN | 1997-07-15 | 237 |
| K964325 | VISUALEYES: VIDEO EYE MONITOR | GWN | 1997-07-15 | 258 |
| K922037 | SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR | LXV | 1992-10-26 | 178 |
| K891008 | VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) | LXV | 1989-05-31 | 89 |
| K863424 | COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE | GWN | 1987-03-23 | 200 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-11-16.
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 Industries, Ltd. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Micromedical Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Micromedical Technologies, Inc.” (first 1987, latest 1997), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Micromedical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micromedical Technologies, Inc. is 200 days.
Which FDA product codes appear under Micromedical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GWN (Nystagmograph, 3); LXV (Apparatus, Vestibular Analysis, 2).
Next steps
- See all 5 Micromedical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWN, Micromedical Technologies, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.