510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142147Substantially Equivalent

Eeva System

Auxogyn, Inc., Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142147 is the FDA 510(k) clearance record for EEVA SYSTEM, a class II device, cleared for Auxogyn, Inc. on under FDA product code PBH (Embryo Image Assessment System, Assisted Reproduction). FDA's definition for product code PBH reads: "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". FDA records list 4 510(k) clearances for Auxogyn, Inc., from to . As of , FDA records show no recalls naming K142147.

Clearance record

Decision date
Received
(111 days to decision)
Product code
PBH Embryo Image Assessment System, Assisted Reproduction
Regulation
21 CFR 884.6195
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Auxogyn, Inc. 1490 O'Brien Dr., Suite A, Menlo Park CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PBH

Trailing 12 months
1 clearance under product code PBH in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PBH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260