Corometrics Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Corometrics Medical Systems, Inc.” (first 1988, latest 1998), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 2 | 2 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 2 | 2 |
| HEL | Monitor, Heart Rate, Fetal, Ultrasonic | 1 | 1 |
Review panels
Most recent Corometrics Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982651 | COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER | HEL | 1998-12-11 | 134 |
| K905000 | ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER | HEM | 1991-01-31 | 85 |
| K903623 | MODEL600 UTERINE ACTIVITY MONITOR | HFM | 1990-11-07 | 90 |
| K891997 | CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER | HFM | 1989-06-08 | 72 |
| K880900 | SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER | HEM | 1988-06-01 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Corometrics Medical Systems, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Corometrics Medical Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Corometrics Medical Systems, Inc.” (first 1988, latest 1998), across 3 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 Corometrics Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Corometrics Medical Systems, Inc. is 90 days.
Which FDA product codes appear under Corometrics Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are HEM (Imager, Ultrasonic Obstetric-Gynecologic, 2); HFM (Monitor, Uterine Contraction, External (For Use In Clinic), 2); HEL (Monitor, Heart Rate, Fetal, Ultrasonic, 1).
Next steps
- See all 5 Corometrics Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HEM, Corometrics Medical Systems, 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 (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.