Cleared Traditional

K212112 - Cardiologs Holter Platform

K212112 is an FDA 510(k) clearance for Cardiologs Holter Platform, manufactured by Cardiologs Technologies. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K212112 · Cardiologs Technologies · Cardiovascular device
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Nov 2021
Decision
135d
Days
Class 2
Risk

K212112 is an FDA 510(k) clearance for the Cardiologs Holter Platform. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardiologs Technologies (Paris, FR). The FDA issued a Cleared decision on November 18, 2021 after a review of 135 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 Cardiologs Technologies devices

FDA 510(k) Submission Details - K212112

510(k) Number K212112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2021
Decision Date November 18, 2021
Days to Decision 135 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 125d · This submission: 135d
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 282
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K212112.
Coala Heart Monitor
K212163 · Coala Life AB · Apr 2022
Electrocardiograph
K212278 · Edan Instruments, Inc. · Apr 2022
LE-12CH
K220362 · Caf Medical Solutions, Inc. · Mar 2022
Scan Monitor
K201456 · Withings SA · Oct 2021
electrocardiograph: SE-1202
K210140 · Edan Instruments, Inc. · Oct 2021
Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
K210560 · Philips Medical Systems · Jun 2021