Cleared Traditional

K172965 - Handheld VitalSigns Monitoring System (FDA 510(k) Clearance)

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

K172965 · Visiomed Technology Co.,Ltd · Cardiovascular device
Dec 2018
Decision
447d
Days
Class 2
Risk

K172965 is an FDA 510(k) clearance for the Handheld VitalSigns Monitoring System. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Visiomed Technology Co.,Ltd (Bao An, Shenzhen,, CN). The FDA issued a Cleared decision on December 17, 2018 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 870.2300 - 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.

Submission Details

510(k) Number K172965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2017
Decision Date December 17, 2018
Days to Decision 447 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
307d slower than avg
Panel avg: 140d · This submission: 447d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 15
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K172965.
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