Level 1 Convective Warmer
FDA 510(k) clearance K181699 · decided 2018-07-26
Clearance details
- K-number
- K181699
- Device name
- Level 1 Convective Warmer
- Applicant
- Smiths Medical Asd, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-27
- Decision date
- 2018-07-26
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- DWJ
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnepolis, MN, US
- Third-party review
- Yes
- 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 |
|---|---|---|
| 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 |
|---|---|---|
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018) | Smiths Medical Asd, Inc. | 2013-05-13 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017) | Smiths Medical Asd, Inc. | 2010-04-21 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016) | Smiths Medical Asd, Inc. | 2009-04-20 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015) | Smiths Medical Asd, Inc. | 2007-11-06 |
| PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014) | Smiths Medical Asd, Inc. | 2007-08-28 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013) | Smiths Medical Asd, Inc. | 2007-04-05 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012) | Smiths Medical Asd, Inc. | 2002-12-17 |
| PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011) | Smiths Medical Asd, Inc. | 2002-10-03 |