510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082704Substantially Equivalent

Birthtrack (A.k.a. Clm)

Barnev, Ltd., Kfar Saba, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082704 is the FDA 510(k) clearance record for BIRTHTRACK (A.K.A. CLM), a class II device, cleared for Barnev, Ltd. on under FDA product code NPB (System, Monitoring, For Progress Of Labor). FDA's definition for product code NPB reads: "This monitoring system for progress of labor provides intrapartum measurement of cervical dilation, fetal head station, and/or other sentinel anatomical markers. This device is intended to be used adjunctively with other diagnostic...". FDA records list 3 510(k) clearances for Barnev, Ltd., from to . As of , FDA records show no recalls naming K082704.

Clearance record

Decision date
Received
(115 days to decision)
Product code
NPB System, Monitoring, For Progress Of Labor
Regulation
21 CFR 884.2800
Device class
Class II
Review panel
Ophthalmic
Applicant
Barnev, Ltd. 20 Hata'As St., Kfar Saba, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPB

Trailing 12 months

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

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