BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
FDA 510(k) clearance K093650 · decided 2010-02-17
Clearance details
- K-number
- K093650
- Device name
- BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-11-25
- Decision date
- 2010-02-17
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- DTY
- Device class
- 2
- Regulation number
- 870.4410
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mounds View, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| SynchroMed Infusion Systems (P860004/S453) | Medtronic, Inc. | 2025-12-19 |
| Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526) | Medtronic, Inc. | 2025-12-18 |
| Activa Deep Brain Stimulation Therapy System (P960009/S514) | Medtronic, Inc. | 2025-12-17 |
| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |