Cardio Metrics, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Cardio Metrics, Inc.” (first 1986, latest 1997), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 9 | 9 |
| DPW | Flowmeter, Blood, Cardiovascular | 4 | 4 |
| ITX | Transducer, Ultrasonic, Diagnostic | 4 | 4 |
| DTP | Defoamer, Cardiopulmonary Bypass | 1 | 1 |
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| JOP | Transducer, Ultrasonic | 1 | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (17)
- Radiology (5)
- General and Plastic Surgery (1)
Most recent Cardio Metrics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972762 | CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES | DQX | 1997-10-14 | 82 |
| K965140 | CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM | DQX | 1997-08-18 | 238 |
| K951567 | CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE | ITX | 1996-10-25 | 570 |
| K961777 | ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 | DQX | 1996-07-31 | 85 |
| K955551 | CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 | DQX | 1996-02-28 | 85 |
| K954913 | CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) | DQX | 1995-11-07 | 35 |
| K952562 | CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE | DQX | 1995-08-29 | 88 |
| K943022 | CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE | DQX | 1994-09-19 | 87 |
| K940984 | CARDIOMETRICS DUALFLOW SWITCH BOX | DQX | 1994-08-18 | 170 |
| K933320 | CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT | IYO | 1994-08-17 | 406 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cardio Metrics, 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 Systems, Inc. (9 510(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 Metrics, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Cardio Metrics, Inc.” (first 1986, latest 1997), across 9 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 Metrics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardio Metrics, Inc. is 90 days.
Which FDA product codes appear under Cardio Metrics, Inc.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 9); DPW (Flowmeter, Blood, Cardiovascular, 4); ITX (Transducer, Ultrasonic, Diagnostic, 4).
Next steps
- See all 23 Cardio Metrics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Cardio Metrics, 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.