510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925040Substantially Equivalent

Telepulse

Biometrix Ltd., Greenwich CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925040 is the FDA 510(k) clearance record for TELEPULSE, a class II device, cleared for Biometrix , Ltd. on under FDA product code JEH (Plethysmograph, Volume). FDA records list 4 510(k) clearances for Biometrix , Ltd., from to . As of , FDA records show no recalls naming K925040.

Clearance record

Decision date
Received
(322 days to decision)
Product code
JEH Plethysmograph, Volume
Regulation
21 CFR 868.1760
Device class
Class II
Review panel
Anesthesiology
Applicant
Biometrix , Ltd. 2 Sound View Dr., Greenwich CT
510(k) summary
Statement
Third party review
No

Clearances, product code JEH

Trailing 12 months

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

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