Obstetrics and Gynecology · 510(k) · 2025
CHLOE BLAST
Fairtility Ltd.. Cleared by FDA on 15 August 2025 under submission K243851, product code PBH (embryo image assessment system, assisted reproduction). What FDA's record says, in FDA's words.
Device record · K243851
- Device. CHLOE BLASTDEVICE
- Company. Fairtility Ltd. (IL)COMPANY
- Decision. 15 August 2025, 510(k), substantially equivalent (traditional review); received 16 December 2024DECISION
- Panel. Obstetrics and GynecologyPANEL
- Product code. PBH, Embryo Image Assessment System, Assisted ReproductionCODE
- Regulation. 21 CFR 884.6195, Class IIREG
- Source. FDA database entry · decision document (14 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
CHLOE BLAST is indicated to provide adjunctive information on events occurring during embryo development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3, when, following morphological assessment, there are multiple embryos deemed suitable for transfer or freezing. CHLOE BLAST is to be used only for the analysis of images captured by the EmbryoScope version D incubator system.
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code PBH. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
21 June 2019 · Malfunction · EMBRYO REPLACEMENT CATHETER, SURE-PRO, WALLACE, + OBTURATOR · SMITHS MEDICAL ASD, INC. · report 3012307300-2019-03611
INFORMATION WAS RECEIVED THAT A THE "POCKET" ON A SMITHS MEDICAL EMBRYO REPLACEMENT CATHETER, SURE-PRO, WALLACE, + OBTURATOR "IS NOT CLOSED. NOT STERILIZED". NO ADVERSE EFFECTS WERE REPORTED.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PBH, in Obstetrics and Gynecology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.