DeviceClearance

Product code PBH— Obstetrics/Gynecology

CHLOE BLAST

Classification name
Embryo Image Assessment System, Assisted Reproduction
Device class
Class 2
Regulation
21 CFR 884.6195
Advisory panel
Obstetrics/Gynecology
Total cleared
5
First cleared
Most recent

FDA classification 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 .”

— U.S. Food and Drug Administration, device classification record for product code PBH under 21 CFR 884.6195, via openFDA

Market context for product code PBH

FDA has cleared 5 devices under product code PBH between 2014 and 2026, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PBH

Recent clearances under product code PBH

Data sourced from openFDA. This site is unofficial and independent of the FDA.