Cleared Traditional

K201914 - HRVWatch-Mini Wrist Monitor

K201914 is an FDA 510(k) clearance for HRVWatch-Mini Wrist Monitor, manufactured by Taiwan Scientific Corporation. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K201914 · Taiwan Scientific Corporation · Cardiovascular device
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Jun 2021
Decision
333d
Days
Class 2
Risk

K201914 is an FDA 510(k) clearance for the HRVWatch-Mini Wrist Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Taiwan Scientific Corporation (New Taipei, TW). The FDA issued a Cleared decision on June 7, 2021 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Taiwan Scientific Corporation devices

FDA 510(k) Submission Details - K201914

510(k) Number K201914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2020
Decision Date June 07, 2021
Days to Decision 333 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
208d slower than avg
Panel avg: 125d · This submission: 333d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 566
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K201914.
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