Cleared Traditional

K854115 - CUSTO PORT 24-H ECG AMBULATORY RECORDER

K854115 is the FDA 510(k) clearance for CUSTO PORT 24-H ECG AMBULATORY RECORDER by Versacor, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K854115 · Versacor, Inc. · Cardiovascular device
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Jan 1986
Decision
111d
Days
Class 2
Risk

K854115 is an FDA 510(k) clearance for the CUSTO PORT 24-H ECG AMBULATORY RECORDER. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Versacor, Inc. (Dayton, US). The FDA issued a Cleared decision on January 27, 1986 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Versacor, Inc. devices

Submission Details

510(k) Number K854115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1985
Decision Date January 27, 1986
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSI Detector And Alarm, Arrhythmia

All 140
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K854115.
SCM-400 HOLTER SYSTEM
K860950 · Fukuda Denshi USA, Inc. · May 1986
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
K853669 · Hewlett-Packard Co. · Mar 1986
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
K855094 · Fukuda Denshi USA, Inc. · Feb 1986
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR
K853352 · Fukuda Denshi USA, Inc. · Nov 1985
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
K853213 · Fukuda Denshi USA, Inc. · Oct 1985
MODEL 78560A CENTRAL STATION PATIENT INFO SYS
K852514 · Hewlett-Packard Co. · Sep 1985