Cardio Data: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cardio Data” (first 1977, latest 1985), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 31 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 3 | 3 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Cardio Data 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853262 | CARDIO DATA PACERECORDER PR3 | DSH | 1985-10-11 | 67 |
| K850136 | CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM | DSI | 1985-02-01 | 18 |
| K834257 | CARDIODATA PACE RECORDER | DSH | 1984-01-30 | 54 |
| K831184 | CARDIO DATA PACEMAKER RECORDER | DSH | 1983-05-09 | 28 |
| K812149 | CARDIO-DATA SYSTEM, #MARK III | DSI | 1981-08-31 | 34 |
| K770264 | PACEGUARD | DXH | 1977-02-16 | 5 |
Recalls
openFDA lists no recalls under a recalling firm named Cardio Data.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cardio Metrics, Inc. (23 510(k)s)
- Cardio Systems, Inc. (9 510(k)s)
- Cardio Flow Inc., (5 510(k)s)
- Cardio Kinetics, Inc. (5 510(k)s)
- Cardio Med Supplies, Inc. (5 510(k)s)
- Cardio Control BV (4 510(k)s)
- Cardio-Dynamics, Inc. (4 510(k)s)
- Cardio-Dynamics Laboratories, Inc. (4 510(k)s)
- Cardio Search, Inc. (4 510(k)s)
- Cardio-Vascular Innovations, Inc. (4 510(k)s)
- Cardio Medical Products, Inc. (3 510(k)s)
- Cardio-Pace Medical, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardio Data?
FDA lists 6 510(k) clearances under the applicant name “Cardio Data” (first 1977, latest 1985), 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 Cardio Data?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardio Data is 31 days.
Which FDA product codes appear under Cardio Data?
The most frequent FDA product codes under this applicant name are DSH (Recorder, Magnetic Tape, Medical, 3); DSI (Detector And Alarm, Arrhythmia, 2); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 1).
Next steps
- See all 6 Cardio Data clearances with predicates and recalls
- Run predicate analysis for product code DSH, Cardio Data'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.