510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140862Substantially Equivalent

Monica Novii Wireless Patch System

Monica Healthcare, Nottingham, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140862 is the FDA 510(k) clearance record for MONICA NOVII WIRELESS PATCH SYSTEM, a class II device, cleared for Monica Healthcare, Ltd. on under FDA product code OSP (Uterine Electromyographic Monitor). FDA's definition for product code OSP reads: "The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton...". FDA records list 4 510(k) clearances for Monica Healthcare, Ltd., from to . As of , FDA records show 2 recalls naming K140862.

Clearance record

Decision date
Received
(146 days to decision)
Product code
OSP Uterine Electromyographic Monitor
Regulation
21 CFR 884.2720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Monica Healthcare, Ltd. Biocity, Pennyfoot St., Nottingham, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OSP

Trailing 12 months

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

FDA records show no clearances under product code OSP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OSP, 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