Cleared Special

K012005 - MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM

K012005 is an FDA 510(k) clearance for MODIFICATION TO ALARMVIEW WIRELESS DATA..., manufactured by Data Critical Corp.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Special 510(k) pathway after a 27-day FDA review.

K012005 · Data Critical Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
27d
Days
Class 2
Risk

K012005 is an FDA 510(k) clearance for the MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Data Critical Corp. (Bothell, US). The FDA issued a Cleared decision on July 24, 2001 after a review of 27 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 - K012005

510(k) Number K012005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2001
Decision Date July 24, 2001
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 118
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K012005.
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX
K012531 · Datex-Ohmeda · Nov 2001
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K013156 · Data Critical Corp. · Oct 2001
MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM
K011999 · Data Critical Corp. · Jul 2001
MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
K012171 · Visicu, Inc. · Jul 2001
ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K010912 · Data Critical Corp. · Apr 2001
FLEXVIEW CLINICAL MONITORING SYSTEM
K003998 · Data Critical Corp. · Mar 2001
K012005 · MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
Download PDF FDA Summary Data Critical Corp.