Cleared Traditional

CARDIOVIT AT-102 (K031557) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031557 · Schiller AG · Cardiovascular device
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Apr 2004
Decision
331d
Days
Class 2
Risk

K031557 is an FDA 510(k) clearance for the CARDIOVIT AT-102. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on April 14, 2004 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Schiller AG devices

Submission Details

510(k) Number K031557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2003
Decision Date April 14, 2004
Days to Decision 331 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 125d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 134
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K031557.
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200
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K042827 · Nihon Kohden America, Inc. · Jan 2005
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K042177 · Ge Medical Systems Information Technologies · Aug 2004
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
K031422 · Philips Medical Systems · Jul 2003
PACEART SYSTEM
K024278 · Medtronic Vascular · May 2003
PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
K020708 · Philips Medical Systems, Inc. · Apr 2002