Hot Pink Pad Warming System— 510(k) K260903

Name: FDA 510(k) clearance K260903
Creator: U.S. Food and Drug Administration
Published: 2026-04-16

Substantially Equivalent

Xodus Medical, Inc.

FDA 510(k) clearance K260903 for Hot Pink Pad Warming System, Substantially Equivalent on 2026-04-16. Applicant: Xodus Medical, Inc.. Device class: 2.

Summary

Xodus Medical's Hot Pink Pad Warming System is filed under product code DWJ (System, Thermal Regulating).

Class II, 21 CFR 870.5900. It came in as a Traditional 510(k), and Cardiovascular is both the classification panel and the review panel.

Xodus Medical filed from New Kensington, Pennsylvania. Review took 29 calendar days (March 18 to April 16, 2026). The record flags it as a third-party review.

Clearance details

Applicant: Xodus Medical, Inc.
Product code: Product code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2026-03-18
Decision date: 2026-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Kensington, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWJ

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K263587 — Arctic Sun Neonatal ArcticGel Pad2026-10-30
K262089 — Disposable Warming Blanket2026-08-21
K261437 — Mistral-Air® Warming System2026-08-07
K260278 — ThermAffyx(TM) Patient Safety System2026-07-08
K252861 — Warming System2026-04-07

More clearances from Xodus Medical, Inc.

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K182080 — Scope Antifogging System2018-09-19
K081647 — ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS2008-08-12
K063587 — XODUS MEDICAL ANTI-FOG SOLUTION2007-01-09
K053321 — LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER2006-01-19
K053433 — CAUTERY TIP CLEANER, MODEL 305002006-01-19

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.