510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K012825Substantially Equivalent

Hearttrends

Lev-El, Ltd., M.P. Misgav, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012825 is the FDA 510(k) clearance record for HEARTTRENDS, a class II device, cleared for Lev-El, Ltd. on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list one 510(k) clearance for Lev-El, Ltd. As of , FDA records show no recalls naming K012825.

Clearance record

Decision date
Received
(208 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
Lev-El, Ltd. Mizpe Aviv, M.P. Misgav, IL
510(k) summary
Summary
Third party review
No

Clearances, product code DQK

Trailing 12 months
26 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20261