HEATER COOLER UNIT, MODEL HCU 30
FDA 510(k) clearance K031544 · decided 2003-08-07
Clearance details
- K-number
- K031544
- Device name
- HEATER COOLER UNIT, MODEL HCU 30
- Applicant
- Jostra AB
- Decision
- Substantially Equivalent
- Date received
- 2003-05-16
- Decision date
- 2003-08-07
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- DWC
- Device class
- 2
- Regulation number
- 870.4250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- The Woodlands, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Jostra AB
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Heater-Cooler System 3T (K220635) | Livanova Deutschland, GmbH | 2022-11-16 |
| Quantum Heater-Cooler (K212657) | Spectrum Medical , Ltd. | 2022-05-06 |
| Heater-Cooler System 3T (K191402) | Livanova Deutschland, GmbH | 2020-02-25 |
| SORIN FLEXTHERM (K140012) | Sorin Group Deutschland GmbH | 2014-01-31 |
| HEATER-COOLER UNIT HCU 40 (K130300) | Maquet Cardiopulmonary, AG | 2013-07-01 |
| HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (K122813) | Cincinnati Sub-Zero Products, Inc. | 2012-12-18 |
| CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 (K102147) | Cardioquip Llp | 2010-11-19 |
| TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM (K071521) | Terumo Cardiovascular Systems Corp. | 2007-11-21 |
| STOCKERT HEATER-COOLER SYSTEM 3T (K052601) | Sorin Group Deutschland GmbH | 2006-06-06 |
| ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER (K014016) | Minntech Corp. | 2002-02-01 |
| ORIGEN BLADDER HOLDER (K003145) | Origen Biomedical, Inc. | 2001-04-20 |
| ALPHA OMEGA DUAL COOLER-HEATER (K001520) | Alpha Omega, Inc. | 2000-11-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: recall (Z-0589-2016) | Maquet Cardiovascular Us Sales, Llc | 2016-01-05 |
| Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine recall (Z-0350-2007) | MAQUET Inc. | 2007-01-25 |