Cleared Traditional

QOCA Portable ECG Monitoring Device (K210179) - FDA 510(k) Clearance

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

K210179 · Quanta Computer, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
557d
Days
Class 2
Risk

K210179 is an FDA 510(k) clearance for the QOCA Portable ECG Monitoring Device. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Quanta Computer, Inc. (Taoyuan City, TW). The FDA issued a Cleared decision on August 2, 2022 after a review of 557 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Quanta Computer, Inc. devices

Submission Details

510(k) Number K210179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2021
Decision Date August 02, 2022
Days to Decision 557 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
432d slower than avg
Panel avg: 125d · This submission: 557d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSH Recorder, Magnetic Tape, Medical
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 - DSH Recorder, Magnetic Tape, Medical

All 34
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K210179.
CardioSTAT® ECG Test Solution
K223049 · Icentia, Inc. · Mar 2023
eWave Monitor
K214073 · Wearlinq, Inc. · Oct 2022
AT-Patch ECG Analysis System
K203638 · Atsens Co., Ltd. · Oct 2022
Strados Remote Electronic Stethoscope Platform (RESP)
K220893 · Strados Labs, Inc. · Apr 2022
LifeLens Wireless ECG Monitor
K203168 · LifeLens Technologies, Inc. · Jul 2021
Zio Monitor
K202359 · iRhythm Technologies, Inc. · May 2021