RK2000 K-THERMIA SYSTEM
FDA 510(k) clearance K882442 · decided 1988-09-06
Clearance details
- K-number
- K882442
- Device name
- RK2000 K-THERMIA SYSTEM
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1988-06-14
- Decision date
- 1988-09-06
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- DWJ
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Valencia, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corp
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 |
|---|---|---|
| Mistral-Air® Warming System (K261437) | The Surgical Company International B.V., doing business as TSC Life | 2026-08-07 |
| ThermAffyx(TM) Patient Safety System (K260278) | Stihler Electronic GmbH | 2026-07-08 |
| Hot Pink Pad Warming System (K260903) | Xodus Medical, Inc. | 2026-04-16 |
| Warming System (K252861) | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-04-07 |
| Arctic Sun Temperature Management System (Model 5000) (K251974) | Medivance, Inc. | 2025-10-24 |
| Celsi Warmer (K242964) | Hadleigh Health Technologies | 2025-06-20 |
| Arctic Sun Stat Temperature Management System (K243942) | Medivance, Inc. | 2025-04-30 |
| HotDog Warming Mattress + Return Electrode (K232627) | Augustine Temperature Management, LLC | 2024-04-18 |
| Cocoon Convective Warming System, Model CWS7000 (K232502) | Care Essentials Pty, Ltd. | 2024-02-21 |
| Medline ComfortTemp Patient Warming System (K231211) | Medline Industries, LP | 2023-12-01 |
| FilteredFlo Warming Blankets (K232638) | Iob Medical, Inc. | 2023-10-24 |
| The IQoolTM System (K232844) | Braincool AB | 2023-10-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |