510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023082Substantially Equivalent

Babycare

Bionet Co., Ltd., Alpharetta GA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023082 is the FDA 510(k) clearance record for BABYCARE, a class II device, cleared for Bionet Company, Ltd. on under FDA product code HEP (Monitor, Blood-Flow, Ultrasonic). FDA records list 14 510(k) clearances for Bionet Company, Ltd., from to . As of , FDA records show no recalls naming K023082.

Clearance record

Decision date
Received
(167 days to decision)
Product code
HEP Monitor, Blood-Flow, Ultrasonic
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Bionet Company, Ltd. 1308 Morningside Park Dr., Alpharetta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HEP

Trailing 12 months

FDA records hold no clearances under product code HEP in the trailing twelve months.

FDA records show no clearances under product code HEP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HEP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260