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FDA 510(k)

Ultra-Fast Warm

K-Number: K260248 · 2026-04-28

ApplicantKitazato Corporation
Decision Date2026-04-28
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Ultra-Fast Warm is a medical device manufactured by Kitazato Corporation. It received FDA 510(k) clearance on 2026-04-28 under approval number K260248. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultra-Fast Warm?

Ultra-Fast Warm is a medical device that received FDA 510(k) clearance on 2026-04-28. It is manufactured by Kitazato Corporation. The 510(k) number is K260248.

When was Ultra-Fast Warm approved by the FDA?

Ultra-Fast Warm received FDA 510(k) clearance on 2026-04-28, under approval number K260248.

What company makes Ultra-Fast Warm?

Ultra-Fast Warm is manufactured by Kitazato Corporation.

What is the FDA product code for Ultra-Fast Warm?

The FDA product code for Ultra-Fast Warm is MQL.

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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