510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052190Substantially Equivalent

Fetal Monitor, Models Bt-300 and Bt-200

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

K052190 is the FDA 510(k) clearance record for FETAL MONITOR, MODELS BT-300 AND BT-200, 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 K052190.

Clearance record

Decision date
Received
(54 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. 340 Shady Grove Rd., Flintville TN
510(k) summary
Summary PDF
Third party review
Yes

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