Cleared Traditional

K133810 - VC150 VITAL SIGNS MONITOR

K133810 is an FDA 510(k) clearance for VC150 VITAL SIGNS MONITOR, manufactured by Innokas Yhtyma. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K133810 · Innokas Yhtyma · Cardiovascular device
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Oct 2014
Decision
318d
Days
Class 2
Risk

K133810 is an FDA 510(k) clearance for the VC150 VITAL SIGNS MONITOR. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Innokas Yhtyma (Kempele, Oulu, FI). The FDA issued a Cleared decision on October 30, 2014 after a review of 318 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: 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 Innokas Yhtyma devices

FDA 510(k) Submission Details - K133810

510(k) Number K133810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2013
Decision Date October 30, 2014
Days to Decision 318 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 125d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

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 175
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K133810.
Unity Network ID
K142840 · Ge Healthcare · Jan 2015
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Masimo Root Monitoring System and Accesories
K142394 · Masimo Corporation · Nov 2014
MASIMO ROOT MONITORING SYSTEM
K140188 · Masimo Corporation · Jun 2014
740 SELECT
K140430 · Cas Medical Systems, Inc. · Jun 2014
HANDHELD MONITOR
K131762 · Guangdong Biolight Meditech Co., Ltd. · Jun 2014