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FDA 510(k)

FreeStyle Comfort (AS200 / FreeStyle Comfort)

K-Number: K250671 · 2025-07-11

ApplicantCaire, Inc.
Decision Date2025-07-11
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FreeStyle Comfort (AS200 / FreeStyle Comfort) is the device name listed in this FDA 510(k) record. The listed applicant is Caire, Inc.. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K250671. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FreeStyle Comfort (AS200 / FreeStyle Comfort)?

FreeStyle Comfort (AS200 / FreeStyle Comfort) is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Caire, Inc.. The 510(k) number is K250671.

When did FreeStyle Comfort (AS200 / FreeStyle Comfort) receive FDA 510(k) clearance?

FreeStyle Comfort (AS200 / FreeStyle Comfort) received FDA 510(k) clearance on 2025-07-11, under 510(k) number K250671.

Who is the listed applicant for FreeStyle Comfort (AS200 / FreeStyle Comfort)?

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

What is the FDA product code for FreeStyle Comfort (AS200 / FreeStyle Comfort)?

The FDA product code for FreeStyle Comfort (AS200 / FreeStyle Comfort) is CAW.

Related Devices (Code: CAW)

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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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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