510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191401Substantially Equivalent

PregSense

Nuvo- Group, Ltd., Tel Aviv, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191401 is the FDA 510(k) clearance record for PregSense, a class II device, cleared for Nuvo- Group , Ltd. on under FDA product code LQK (Home Uterine Activity Monitor). FDA records list 3 510(k) clearances for Nuvo- Group , Ltd., from to . As of , FDA records show no recalls naming K191401.

Clearance record

Decision date
Received
(308 days to decision)
Product code
LQK Home Uterine Activity Monitor
Regulation
21 CFR 884.2730
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Nuvo- Group , Ltd. Yigal Alon 94. St., Alon Tower 1, Tel Aviv, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LQK

Trailing 12 months
1 clearance under product code LQK in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LQK, 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 20261
October 20260