Cardio Systems, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Cardio Systems, Inc.” (first 1979, latest 2013), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 133 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 | 1 | 67 |
| 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 |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 2 | 2 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| INX | Bed, Air Fluidized | 1 | 1 |
| IOQ | Bed, Flotation Therapy, Powered | 1 | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 | 1 |
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | 1 | 1 |
Review panels
- Cardiovascular (6)
- Physical Medicine (2)
- General Hospital (1)
Most recent Cardio Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131092 | STEALTH 360 ORBITAL PAD SYSTEM | MCW | 2013-06-24 | 67 |
| K081944 | MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM | MCW | 2008-08-14 | 37 |
| K972022 | ZAK-2000 | FNM | 1998-01-22 | 234 |
| K934689 | LOW AIR LOSS MATTRESS, MODIFICATION | INX | 1994-02-02 | 163 |
| K921500 | CENTRI-SAFE(TM) VALVE | MJJ | 1992-09-15 | 168 |
| K882177 | ADD-ON TO CRITICAL PATIENT CARE BED | IOQ | 1988-12-01 | 191 |
| K852736 | BAYLOR RAPID AUTOTRANSFUSION SYSTEM | CAC | 1985-09-18 | 133 |
| K792152 | CARDIOPLEGIA SOLUTION ADMIN. SET | DWF | 1979-11-13 | 22 |
| K792151 | OXYGENATOR GAS LINE FILTER | KRI | 1979-11-13 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Cardio 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.
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 Data (6 510(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 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 Systems, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Cardio Systems, Inc.” (first 1979, latest 2013), across 8 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 Cardio Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardio Systems, Inc. is 133 days.
Which FDA product codes appear under Cardio Systems, Inc.?
The most frequent FDA product codes under this applicant name are MCW (Catheter, Peripheral, Atherectomy, 2); CAC (Apparatus, Autotransfusion, 1); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1).
Next steps
- See all 9 Cardio Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MCW, Cardio 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, 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.