Cleared Traditional

K854115 - CUSTO PORT 24-H ECG AMBULATORY RECORDER

K854115 is an FDA 510(k) clearance for CUSTO PORT 24-H ECG AMBULATORY RECORDER, manufactured by Versacor, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K854115

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.

DSI Device Classification - Class 2, Special Controls

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 314
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K854115.
MEDILOG 2500 SYSTEM
K860078 · Oxford Medilog, Inc. · Feb 1986
MEDILOG 4500 SYSTEM
K860079 · Oxford Medilog, Inc. · Feb 1986
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
K855094 · Fukuda Denshi USA, Inc. · Feb 1986
MEDILOG M6
K852892 · Oxford Medilog, Inc. · Dec 1985
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