Accucore, Inc.: FDA clearances and approvals
Accucore, Inc. has 9 FDA 510(k) clearances (first 1987, latest 1995), across 4 product codes in 1 review panel. Median 510(k) review time: 80 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 4 | 4 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 3 | 3 |
| DPS | Electrocardiograph | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
Review panels
- Cardiovascular (9)
Most recent Accucore, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942147 | PACIFIC COMMUNICATIONS MODEL 1100 | DSI | 1995-01-30 | 272 |
| K925411 | MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR | DSI | 1993-02-25 | 122 |
| K913576 | DATASCOPE MODEL VISA CENTRAL MONITOR | DSI | 1992-01-28 | 169 |
| K913400 | MODEL SCR-1000 | DXH | 1991-08-21 | 22 |
| K901031 | PCI MODEL 2041-PC TELEMETRY MONITOR | DRT | 1990-05-17 | 72 |
| K896775 | PCI MODEL 2041-B TELEMETRY MONITOR | DSI | 1990-05-17 | 167 |
| K901032 | PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA | DPS | 1990-04-04 | 29 |
| K894340 | PCI MODEL 2041-A TELEMETRY MONITOR | DXH | 1989-10-02 | 80 |
| K874387 | PCI MODEL RS100 TELEMETRY MONITOR | DXH | 1987-12-18 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Accucore, 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 Accucore, Inc. have?
Accucore, Inc. has 9 FDA 510(k) clearances (first 1987, latest 1995), across 4 product codes in 1 review panel.
How long does FDA take to clear Accucore, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Accucore, Inc.'s cleared 510(k)s is 80 days.
What devices does Accucore, Inc. make?
Its most frequent FDA product codes are DSI (Detector And Alarm, Arrhythmia, 4); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 3); DPS (Electrocardiograph, 1).
Has Accucore, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Accucore, Inc. Related entities may recall under other names.
Next steps
- See all 9 Accucore, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Accucore, 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.