Cleared Traditional

K193177 - CER-S

K193177 is an FDA 510(k) clearance for CER-S, manufactured by Cardiocalm. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K193177 · Cardiocalm · Cardiovascular device
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Aug 2020
Decision
282d
Days
Class 2
Risk

K193177 is an FDA 510(k) clearance for the CER-S. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Cardiocalm (Montichiari, IT). The FDA issued a Cleared decision on August 26, 2020 after a review of 282 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Cardiocalm devices

FDA 510(k) Submission Details - K193177

510(k) Number K193177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2019
Decision Date August 26, 2020
Days to Decision 282 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
157d slower than avg
Panel avg: 125d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLO Device Classification - Class 2, Special Controls

Product Code MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

All 21
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K193177.
Philips Holter Analysis System
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K200833 · Vivaquant, Inc. · Sep 2020
Faros Mobile
K182030 · Bittium Biosignals , Ltd. · Nov 2018
CARDIOSPY ECG HOLTER SYSTEMS
K140847 · Labtech Kft. · Dec 2014
CV3000 HOLTER ANALYSIS SYSTEM
K131897 · Vales & Hills Biomedical Tech. , Ltd. · Nov 2013