Cleared Abbreviated

K101445 - VITAL SIGNS MONITOR-VSM 6000 SERIES

K101445 is an FDA 510(k) clearance for VITAL SIGNS MONITOR-VSM 6000 SERIES, manufactured by Welch Allyn, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Abbreviated 510(k) pathway after a 15-day FDA review.

K101445 · Welch Allyn, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
15d
Days
Class 2
Risk

K101445 is an FDA 510(k) clearance for the VITAL SIGNS MONITOR-VSM 6000 SERIES. 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 June 8, 2010 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K101445

510(k) Number K101445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2010
Decision Date June 08, 2010
Days to Decision 15 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 307
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K101445.
MD2000B VITAL SIGN MONITOR, MODEL MD2000B
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V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
K101259 · Taidoc Technology Corporation · Jun 2010
PATIENT MONITOR, MODEL PM50
K101127 · Contec Medical System Co., Ltd. · Jun 2010
TEMPUS IC PROFESSIONAL PATIENT MONITOR
K101264 · Remote Diagnostic Technologies , Ltd. · May 2010
STELLAR 300
K093017 · Larsen & Toubro Limited · Apr 2010
VITAL SYNC MODEL 5000 SERIES
K093422 · Somanetics Corp. · Apr 2010
K101445 · VITAL SIGNS MONITOR-VSM 6000 SERIES
Download PDF FDA Summary Welch Allyn, Inc.