510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103545Substantially Equivalent

Bt-350

Bistos co., Ltd., Brooklyn NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103545 is the FDA 510(k) clearance record for BT-350, a class II device, cleared for Bistos Co., Ltd. on under FDA product code HGM (System, Monitoring, Perinatal). FDA records list 11 510(k) clearances for Bistos Co., Ltd., from to . As of , FDA records show no recalls naming K103545.

Clearance record

Decision date
Received
(162 days to decision)
Product code
HGM System, Monitoring, Perinatal
Regulation
21 CFR 884.2740
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Bistos Co., Ltd. 4802 Glenwood Rd., Brooklyn NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HGM

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