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FDA 510(k)

CHLOE BLAST

K-Number: K243851 · 2025-08-15

ApplicantFairtility , Ltd.
Decision Date2025-08-15
Product CodePBH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CHLOE BLAST is the device name listed in this FDA 510(k) record. The listed applicant is Fairtility , Ltd.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K243851. The device is classified under product code PBH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLOE BLAST?

CHLOE BLAST is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Fairtility , Ltd.. The 510(k) number is K243851.

When did CHLOE BLAST receive FDA 510(k) clearance?

CHLOE BLAST received FDA 510(k) clearance on 2025-08-15, under 510(k) number K243851.

Who is the listed applicant for CHLOE BLAST?

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

What is the FDA product code for CHLOE BLAST?

The FDA product code for CHLOE BLAST is PBH.

Related Devices (Code: PBH)

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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