Mini-Mitter Co., Inc.: FDA clearances and approvals
Mini-Mitter Co., Inc. has 5 FDA 510(k) clearances (first 1999, latest 2004), across 3 product codes in 2 review panels. Median 510(k) review time: 164 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 |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | 3 | 3 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| GWK | Conditioner, Signal, Physiological | 1 | 1 |
Review panels
- Neurology (4)
- General Hospital (1)
Most recent Mini-Mitter Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033534 | VITALSENSE | FLL | 2004-04-22 | 164 |
| K011430 | ACTIWARE-PLMS | GWQ | 2001-05-31 | 22 |
| K991045 | MINI-LOGGER SERIES 2000 | GWK | 1999-09-21 | 176 |
| K991033 | ACTIWATCH-SCORE | GWQ | 1999-06-23 | 86 |
| K983533 | ACTIWATCH | GWQ | 1999-03-23 | 166 |
Recalls
openFDA lists no recalls under a recalling firm named Mini-Mitter Co., 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 Mini-Mitter Co., Inc. have?
Mini-Mitter Co., Inc. has 5 FDA 510(k) clearances (first 1999, latest 2004), across 3 product codes in 2 review panels.
How long does FDA take to clear Mini-Mitter Co., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mini-Mitter Co., Inc.'s cleared 510(k)s is 164 days.
What devices does Mini-Mitter Co., Inc. make?
Its most frequent FDA product codes are GWQ (Full-Montage Standard Electroencephalograph, 3); FLL (Continuous Measurement Thermometer, 1); GWK (Conditioner, Signal, Physiological, 1).
Has Mini-Mitter Co., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mini-Mitter Co., Inc. Related entities may recall under other names.
Next steps
- See all 5 Mini-Mitter Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWQ, Mini-Mitter Co., 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.