Cleared Traditional

K183425 - CARDIOVIT AT-102 G2 (FDA 510(k) Clearance)

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

K183425 · Schiller AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
447d
Days
Class 2
Risk

K183425 is an FDA 510(k) clearance for the CARDIOVIT AT-102 G2. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on March 2, 2020 after a review of 447 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Schiller AG devices

Submission Details

510(k) Number K183425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2018
Decision Date March 02, 2020
Days to Decision 447 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
322d slower than avg
Panel avg: 125d · This submission: 447d
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 574
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K183425.
MAC 7 Resting ECG Analysis System
K251670 · Ge Medical Systems Information Technologies, Inc. · Jan 2026
AccurECG Analysis System (v2.0)
K252361 · Accurkardia, Inc. · Dec 2025
Withings BeamO (SCT02)
K252474 · Withings · Nov 2025
Cardiologs Holter Platform
K250569 · Philips France Commercial · Aug 2025
ZBPro Diagnostic
K243252 · Zbeats, Inc. · Jul 2025
Masimo W1
K243305 · Masimo Corporation · Apr 2025