510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K860237Substantially Equivalent

Omf-7101 Fetal Monitor

Nihon Kohden America Inc, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860237 is the FDA 510(k) clearance record for OMF-7101 FETAL MONITOR, a class II device, cleared for Nihon Kohden America, Inc. on under FDA product code HGM (System, Monitoring, Perinatal). FDA records list 166 510(k) clearances for Nihon Kohden America, Inc., from to . As of , FDA records show no recalls naming K860237.

Clearance record

Decision date
Received
(225 days to decision)
Product code
HGM System, Monitoring, Perinatal
Regulation
21 CFR 884.2740
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Nihon Kohden America, Inc. 17112 Armstrong Ave., Irvine CA
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