Cardio Kinetics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cardio Kinetics, Inc.” (first 1979, latest 1982), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 27 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 |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | 3 | 3 |
| DSF | Recorder, Paper Chart | 2 | 2 |
Review panels
- Cardiovascular (5)
Most recent Cardio Kinetics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823215 | CKG 8800 | DSB | 1982-11-24 | 27 |
| K822020 | CKG 8000 | DSB | 1982-08-06 | 28 |
| K801485 | SERIES 602 CKG RECORDER (MODIFIED) | DSF | 1980-07-08 | 14 |
| K800851 | SERIES 602 CKGTM RECORDER | DSF | 1980-04-24 | 9 |
| K792051 | CKG CARDIOKYMOGRAPH | DSB | 1979-11-13 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Cardio Kinetics, 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.
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 Data (6 510(k)s)
- Cardio Flow Inc., (5 510(k)s)
- Cardio Med Supplies, Inc. (5 510(k)s)
- Cardio Control BV (4 510(k)s)
- Cardio Search, Inc. (4 510(k)s)
- Cardio Medical Products, Inc. (3 510(k)s)
- Cardio Pulmonary Instruments (3 510(k)s)
- Cardio Thoracic Systems (3 510(k)s)
- Cardio Design Pty. , Ltd. (2 510(k)s)
- Cardio Display Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardio Kinetics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Cardio Kinetics, Inc.” (first 1979, latest 1982), across 2 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 Kinetics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardio Kinetics, Inc. is 27 days.
Which FDA product codes appear under Cardio Kinetics, Inc.?
The most frequent FDA product codes under this applicant name are DSB (Plethysmograph, Impedance, 3); DSF (Recorder, Paper Chart, 2).
Next steps
- See all 5 Cardio Kinetics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSB, Cardio Kinetics, 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, 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.