DTY
8 FDA 510(k) clearances · Product code
143 daysmedian time to decision
185 days90th percentile
8clearances measured
FDA profile
- Official device name
- Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4410
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1999: 2 · 2010: 130 · 2011: 158 · 2012: 20 · 2013: 18 · 2014: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM (K093650) | Medtronic, Inc. | 2010-02-17 |
| CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 (K963698) | International Biophysics Corp. | 1997-03-20 |
| BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM (K954501) | Medtronic Bio-Medicus, Inc. | 1996-01-16 |
| CDI (TM) SYSTEM 100 MONITORING SYSTEM (K902654) | 3M Health Care, Ltd. | 1990-11-05 |
| PERFUSION MONITOR (K900860) | Cardio Metrics, Inc. | 1990-08-14 |
| MODIFIED GAS-STAT(TM) MONITORING SYSTEM (K864703) | Cardiovascular Devices, Inc. | 1987-02-19 |
| GAST STAT MONITORING SYSTEM (K840749) | Cardiovascular Devices, Inc. | 1984-04-17 |
| EXTRACORPOREAL BLOOD GAS SYSTEM (K822000) | Cardiovascular Devices, Inc. | 1982-12-22 |
Track DTY automatically
Every clearance here is in the API, with alerts when new ones post.