510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K854115Substantially Equivalent

Custo Port 24-H ECG Ambulatory Recorder

Versacor, Inc., Dayton OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854115 is the FDA 510(k) clearance record for CUSTO PORT 24-H ECG AMBULATORY RECORDER, a class II device, cleared for Versacor, Inc. on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list 2 510(k) clearances for Versacor, Inc., from to . As of , FDA records show no recalls naming K854115.

Clearance record

Decision date
Received
(111 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Versacor, Inc. 405 Grand Ave., Dayton OH
Third party review
No

Clearances, product code DSI

Trailing 12 months
1 clearance under product code DSI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260