Skip to content

Chloe Blast Embryo Image Assessment System

by Fairtility, Ltd.

510(k) K243851

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243851↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK243851 Date15 Aug 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Chloe Blast
510(k) Number
FDA Product Code
PBH
FDA applicant
Fairtility , Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.6195
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Chloe Blast is an Embryo Image Assessment System designed for assisted reproduction. It evaluates embryo quality by capturing and analyzing high-resolution images to support selection for transfer or cryopreservation, aiding in reproductive success outcomes.

This system is intended for use in clinical fertility settings, supplied sterile for single-use. It operates under FDA 510(k) clearance and MDR compliance, with model references 3009107689, 3042972064, and 3042372505. Storage and handling follow manufacturer guidelines to maintain sterility and functionality.

Other devices from Fairtility, Ltd.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical setting is the Chloe Blast designed for and how does it improve embryo selection?

    The Chloe Blast is specifically designed for clinical fertility settings, such as fertility clinics or assisted reproduction centers. It improves embryo selection by capturing and analyzing high-resolution images of embryos to evaluate their quality. This assessment helps clinicians make informed decisions when choosing which embryos to transfer or cryopreserve, ultimately supporting better reproductive success outcomes.

  • Is the Chloe Blast system intended for single-use or reusable applications, and how should it be stored?

    The Chloe Blast is supplied sterile for single-use only, meaning each unit is intended for one-time use in embryo imaging. To maintain sterility and functionality, storage and handling must follow the manufacturer’s guidelines, which are detailed in the accompanying documentation. Improper storage could compromise performance or safety.

  • What regulatory pathways does the Chloe Blast follow, and which advisory committee was involved in its review?

    The Chloe Blast operates under FDA 510(k) clearance and MDR compliance, confirming its regulatory approval status. Its review was conducted by the Obstetrics/Gynecology (OB) Advisory Committee, which evaluates devices in the Product Code PBH category—Embryo Image Assessment Systems for assisted reproduction. The system was deemed substantially equivalent to predicate devices.

  • What model references or identifiers should I check when ordering the Chloe Blast?

    The Chloe Blast is available under three distinct model references: 3009107689, 3042972064, and 3042372505. These identifiers correspond to the specific regulatory registration numbers and should be used when placing orders to ensure compatibility with your facility’s needs and inventory systems.