Cleared Traditional

K243851 - CHLOE BLAST (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence.

K243851 · Fairtility , Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Aug 2025
Decision
242d
Days
Class 2
Risk

K243851 is an FDA 510(k) clearance for the CHLOE BLAST. Classified as Embryo Image Assessment System, Assisted Reproduction (product code PBH), Class II - Special Controls.

Submitted by Fairtility , Ltd. (Tel-Aviv, IL). The FDA issued a Cleared decision on August 15, 2025 after a review of 242 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6195 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fairtility , Ltd. devices

Submission Details

510(k) Number K243851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2024
Decision Date August 15, 2025
Days to Decision 242 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 160d · This submission: 242d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PBH Embryo Image Assessment System, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6195
Definition The Device Will Obtain And Analyze Light Microscopy Images Of Developing Embryos. This Device Provides Information To Aid In The Selection Of Embryo(s) For Transfer When There Are Multiple Embryos Deemed Suitable For Transfer Or Freezing .
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Sfadc, LLC
Susan Alpert

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT05455281 Completed Observational Industry-sponsored

Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation

A Pilot, Observational, Prospective Study to Evaluate the Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization

55
Patients (actual)
3
Sites
Condition studied Fertility Disorders
Eligibility Female only · 18 Years+
Principal investigator Yossi Gilgun-Sherki, PhD, MBA
Sponsor Fairtility (industry)
Started 2022-07-27 → Primary completion 2023-06-27 → Completed 2023-07-27
Primary outcome
The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for a subset of good/fair embryos
Secondary outcome
The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for all embryos
Study completed - no results published. This trial concluded in 2023 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov