Cleared Special

K073094 - VITALLINK3 MOBILE VITAL SIGNS SYSTEM

K073094 is an FDA 510(k) clearance for VITALLINK3 MOBILE VITAL SIGNS SYSTEM, manufactured by Telemedic Systems, Ltd.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 64-day FDA review.

K073094 · Telemedic Systems, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
64d
Days
Class 2
Risk

K073094 is an FDA 510(k) clearance for the VITALLINK3 MOBILE VITAL SIGNS SYSTEM. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Telemedic Systems, Ltd. (Taunton, Somerset, GB). The FDA issued a Cleared decision on January 4, 2008 after a review of 64 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K073094

510(k) Number K073094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2007
Decision Date January 04, 2008
Days to Decision 64 days
Submission Type Special
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
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

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 307
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K073094.
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STAR 55
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TESLA GUARD, MODEL EFT G04
K071802 · Mammendorfer Institut Fur Physik Und Medizin GmbH · Nov 2007
MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR
K072516 · Midmark Diagnostics Group · Oct 2007
PLANET 55
K071472 · Larsen & Toubro Limited · Sep 2007
K073094 · VITALLINK3 MOBILE VITAL SIGNS SYSTEM
Download PDF FDA Summary Telemedic Systems, Lt…