Cleared Traditional

K852281 - SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER

K852281 is an FDA 510(k) clearance for SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER, manufactured by Armstrong Ind., Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K852281 · Armstrong Ind., Inc. · Cardiovascular device
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Oct 1985
Decision
133d
Days
Class 2
Risk

K852281 is an FDA 510(k) clearance for the SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Armstrong Ind., Inc. (Northbrook, US). The FDA issued a Cleared decision on October 9, 1985 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Armstrong Ind., Inc. devices

FDA 510(k) Submission Details - K852281

510(k) Number K852281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date October 09, 1985
Days to Decision 133 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 125d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 455
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K852281.
CARDIOFAX ECG-6353
K860212 · Nihon Kohden America, Inc. · Apr 1986
CARDIMAX FX-1164
K853979 · Brentwood Instruments, Inc. · Feb 1986
ESCORT ECG MONITOR SIEMENS SIRECUST 466
K854234 · Medical Data Electronics · Jan 1986
VSM-5
K852322 · Physio-Control Corp. · Sep 1985
CARDIOSTAT 3 RECORDER
K851044 · Siemens Elema AB · Jun 1985
CARDIOSTAT 1 ECG RECORDER
K844392 · Siemens Elema AB · Apr 1985