Cleared Traditional

K962473 - (VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH

K962473 is an FDA 510(k) clearance for (VCOM, manufactured by Data Critical Corporation. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 499-day FDA review.

K962473 · Data Critical Corporation · Cardiovascular device
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Nov 1997
Decision
499d
Days
Class 2
Risk

K962473 is an FDA 510(k) clearance for the (VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTE.... Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Data Critical Corporation (Tustin, US). The FDA issued a Cleared decision on November 6, 1997 after a review of 499 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.

View all Data Critical Corporation devices

FDA 510(k) Submission Details - K962473

510(k) Number K962473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received June 25, 1996
Decision Date November 06, 1997
Days to Decision 499 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
374d slower than avg
Panel avg: 125d · This submission: 499d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
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 - MSX System, Network And Communication, Physiological Monitors

All 101
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K962473.
DATEX-ENGSTROM NETWORK
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