510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K033451Substantially Equivalent

Heartrak Smart At/heartrak Smart2

Universal Medical, Inc., Philadelphia PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033451 is the FDA 510(k) clearance record for HEARTRAK SMART AT/HEARTRAK SMART2, a class II device, cleared for Universal Medical, Inc. on under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone). FDA records list 8 510(k) clearances for Universal Medical, Inc., from to . As of , FDA records show no recalls naming K033451.

Clearance record

Decision date
Received
(98 days to decision)
Product code
DXH Transmitters And Receivers, Electrocardiograph, Telephone
Regulation
21 CFR 870.2920
Device class
Class II
Review panel
Cardiovascular
Applicant
Universal Medical, Inc. One Commerce Sq., Philadelphia PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXH

Trailing 12 months
4 clearances under product code DXH in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DXH, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260