Hot Pink Pad Warming System
FDA 510(k) K260903 · Xodus Medical, Inc.
510(k) numberK260903
Submission
- Device name
- Hot Pink Pad Warming System
- Applicant
- Xodus Medical, Inc.
New Kensington, PA, US - Received
- March 18, 2026
- Decision date
- April 16, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DWJ – System, Thermal Regulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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|---|---|---|---|
| K262089 | Disposable Warming BlanketDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 08/21/2026SE |
| K261437 | Mistral-Air® Warming SystemDWJ · Special | The Surgical Company International B.V., doing… | 08/07/2026SE |
| K260278 | ThermAffyx(TM) Patient Safety SystemDWJ · Traditional | Stihler Electronic GmbH | 07/08/2026SE |
| K252861 | Warming SystemDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 04/07/2026SE |
| K251974 | Arctic Sun Temperature Management System (Model 5000)DWJ · Traditional | Medivance, Inc. | 10/24/2025SE |
| K242964 | Celsi WarmerDWJ · Traditional | Hadleigh Health Technologies | 06/20/2025SE |
| K243942 | Arctic Sun Stat Temperature Management SystemDWJ · Traditional | Medivance, Inc. | 04/30/2025SE |
| K232627 | HotDog Warming Mattress + Return ElectrodeDWJ · Special | Augustine Temperature Management, LLC | 04/18/2024SE |
| K232502 | Cocoon Convective Warming System, Model CWS7000DWJ · Traditional | Care Essentials Pty, Ltd. | 02/21/2024SE |
| K231211 | Medline ComfortTemp Patient Warming SystemDWJ · Traditional | Medline Industries, LP | 12/01/2023SE |
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| 510(k) | Device | Decision |
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| K182080 | Scope Antifogging SystemGCJ · Traditional | 09/19/2018SE |
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| K063587 | Xodus Medical Anti-Fog SolutionOCT · Traditional | 01/09/2007SE |
| K053433 | Cautery Tip Cleaner, Model 30500GEI · Traditional | 01/19/2006SE |
| K053321 | Light Guard Light Handle and Light Handle CoverFTA · Traditional | 01/19/2006SE |
Questions and answers
When was Hot Pink Pad Warming System cleared by the FDA?
Hot Pink Pad Warming System (K260903) received a 510(k) decision of Substantially Equivalent on April 16, 2026, 29 days after the submission was received.
What is the product code of K260903?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.