Cleared Traditional

K142356 - Connex Spot Monitor,901058 Vital Signs Monitor Core (FDA 510(k) Clearance)

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

K142356 · Welch Allyn, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
116d
Days
Class 2
Risk

K142356 is an FDA 510(k) clearance for the Connex Spot Monitor,901058 Vital Signs Monitor Core. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on December 19, 2014 after a review of 116 days - within the typical 510(k) review window.

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. 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 Welch Allyn, Inc. devices

Submission Details

510(k) Number K142356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2014
Decision Date December 19, 2014
Days to Decision 116 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
9d faster than avg
Panel avg: 125d · This submission: 116d
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 304
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K142356.
c-med0 alpha
K253436 · Cosinuss GmbH · Apr 2026
WAVE Clinical Platform (2.0.000)
K250135 · Baxter Healthcare Corp/ Excel Medical · Jan 2026
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
K241766 · Fysicon BV · Aug 2025
Empatica Health Monitoring Platform
K242737 · Empatica S.R.L. · Jun 2025
WARD-CSS (v1.2.x)
K241958 · Ward 24/7 Aps · Feb 2025
iCare APP
K243146 · Ihealth Labs, Inc. · Feb 2025