Grandcor Medical Systems: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Grandcor Medical Systems” (first 1986, latest 1991), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 4 | 4 |
| BZC | Calculator, Pulmonary Function Data | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| ISD | Exerciser, Measuring | 1 | 1 |
Review panels
- Cardiovascular (6)
- Anesthesiology (1)
- Physical Medicine (1)
Most recent Grandcor Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905480 | SPIROSCOPE | BZC | 1991-05-06 | 151 |
| K895547 | GRANDCOR/CARDIOLINE ECT STRESS TESTING | DSI | 1990-03-13 | 181 |
| K883410 | CARDIOMEGA-T | DSI | 1988-10-17 | 67 |
| K871890 | CARDIO-MEGA SYSTEM | DSI | 1987-06-12 | 28 |
| K864260 | APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) | DRX | 1987-05-11 | 194 |
| K864978 | APPLISCOPE | DPS | 1987-02-19 | 59 |
| K864581 | APPLIDYN | ISD | 1987-01-21 | 62 |
| K862375 | CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM | DSI | 1986-07-01 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named Grandcor Medical Systems.
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 Grandcor Medical Systems?
FDA lists 8 510(k) clearances under the applicant name “Grandcor Medical Systems” (first 1986, latest 1991), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Grandcor Medical Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Grandcor Medical Systems is 64 days.
Which FDA product codes appear under Grandcor Medical Systems?
The most frequent FDA product codes under this applicant name are DSI (Detector And Alarm, Arrhythmia, 4); BZC (Calculator, Pulmonary Function Data, 1); DPS (Electrocardiograph, 1).
Next steps
- See all 8 Grandcor Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code DSI, Grandcor Medical Systems'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.