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FDA 510(k)

Hot Pink Pad Warming System

K-Number: K260903 · 2026-04-16

ApplicantXodus Medical, Inc.
Decision Date2026-04-16
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hot Pink Pad Warming System is the device name listed in this FDA 510(k) record. The listed applicant is Xodus Medical, Inc.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K260903. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hot Pink Pad Warming System?

Hot Pink Pad Warming System is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Xodus Medical, Inc.. The 510(k) number is K260903.

When did Hot Pink Pad Warming System receive FDA 510(k) clearance?

Hot Pink Pad Warming System received FDA 510(k) clearance on 2026-04-16, under 510(k) number K260903.

Who is the listed applicant for Hot Pink Pad Warming System?

The FDA 510(k) record lists Xodus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hot Pink Pad Warming System?

The FDA product code for Hot Pink Pad Warming System is DWJ.

Other records listing Xodus Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.K242964Celsi WarmerHadleigh Health TechnologiesK243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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