Medical Measurement Systems B.V.: FDA clearances and approvals
Medical Measurement Systems B.V. has 7 FDA 510(k) clearances (first 2004, latest 2012), across 3 product codes in 3 review panels. Median 510(k) review time: 117 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 120 |
| 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 |
|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | 5 | 5 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Gastroenterology and Urology (5)
- Neurology (1)
- Radiology (1)
Most recent Medical Measurement Systems B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121014 | SOLAR GI | FFX | 2012-08-01 | 120 |
| K071094 | MODIFICATION TO SOLAR GI | FFX | 2007-08-13 | 117 |
| K060166 | OHMEGA | FFX | 2006-04-21 | 88 |
| K052338 | SOLAR GI | FFX | 2005-12-15 | 111 |
| K050993 | MMS VIDEO OPTION | LLZ | 2005-05-26 | 37 |
| K031084 | SOLAR GI SYSTEM | FFX | 2004-03-19 | 350 |
| K031930 | HIGH SPEED EMG MODULE | GWF | 2004-03-03 | 254 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Measurement Systems B.V..
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 Medical Measurement Systems B.V. have?
Medical Measurement Systems B.V. has 7 FDA 510(k) clearances (first 2004, latest 2012), across 3 product codes in 3 review panels.
How long does FDA take to clear Medical Measurement Systems B.V.'s 510(k)s?
The median time from FDA receipt to decision across Medical Measurement Systems B.V.'s cleared 510(k)s is 117 days.
What devices does Medical Measurement Systems B.V. make?
Its most frequent FDA product codes are FFX (System, Gastrointestinal Motility (Electrical), 5); GWF (Stimulator, Electrical, Evoked Response, 1); LLZ (System, Image Processing, Radiological, 1).
Has Medical Measurement Systems B.V. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medical Measurement Systems B.V. Related entities may recall under other names.
Next steps
- See all 7 Medical Measurement Systems B.V. clearances with predicates and recalls
- Run predicate analysis for product code FFX, Medical Measurement Systems B.V.'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.