Medical Measurements, Inc.: FDA clearances and approvals
Medical Measurements, Inc. has 8 FDA 510(k) clearances (first 1980, latest 1992), across 7 product codes in 5 review panels. Median 510(k) review time: 26 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 |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | 2 | 2 |
| BYR | Transducer, Gas Pressure, Differential | 1 | 1 |
| DXO | Transducer, Pressure, Catheter Tip | 1 | 1 |
| FCK | Instrument, Biopsy, Suction | 1 | 1 |
| FES | Recorder, External, Pressure, Amplifier & Transducer | 1 | 1 |
| FFX | System, Gastrointestinal Motility (Electrical) | 1 | 1 |
| KXO | Monitor, Pressure, Intrauterine | 1 | 1 |
Review panels
- Gastroenterology and Urology (3)
- Neurology (2)
- Anesthesiology (1)
- Cardiovascular (1)
- Obstetrics and Gynecology (1)
Most recent Medical Measurements, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921062 | GAELTEC MPR SERIES | FFX | 1992-07-30 | 147 |
| K902097 | MODEL TR RECTAL SUCTION BIOPSY TUBE | FCK | 1990-07-27 | 80 |
| K863479 | MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL | GWM | 1986-10-14 | 35 |
| K801757 | MMI/GAELTEC CATHETER TIP PRESS. TRANSDU | FES | 1980-08-27 | 30 |
| K801756 | MMI/GAELTEC CATHETER TIP TRANSDUC | DXO | 1980-08-20 | 23 |
| K801880 | MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS | BYR | 1980-08-14 | 7 |
| K801758 | MMI/GAELTEC CATHETER INTRAUTERINE | KXO | 1980-08-14 | 17 |
| K801755 | MMI/GAELTEC CATHETER TIP PRESSURE | GWM | 1980-08-13 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Measurements, 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 Medical Measurements, Inc. have?
Medical Measurements, Inc. has 8 FDA 510(k) clearances (first 1980, latest 1992), across 7 product codes in 5 review panels.
How long does FDA take to clear Medical Measurements, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medical Measurements, Inc.'s cleared 510(k)s is 26 days.
What devices does Medical Measurements, Inc. make?
Its most frequent FDA product codes are GWM (Device, Monitoring, Intracranial Pressure, 2); BYR (Transducer, Gas Pressure, Differential, 1); DXO (Transducer, Pressure, Catheter Tip, 1).
Has Medical Measurements, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medical Measurements, Inc. Related entities may recall under other names.
Next steps
- See all 8 Medical Measurements, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWM, Medical Measurements, 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.