Cleared Traditional

K012226 - MONITORING SYSTEM

K012226 is an FDA 510(k) clearance for MONITORING SYSTEM, manufactured by Schiller AG. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K012226 · Schiller AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
266d
Days
Class 2
Risk

K012226 is an FDA 510(k) clearance for the MONITORING SYSTEM,MODEL ARGUS PB-1000. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on April 8, 2002 after a review of 266 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Schiller AG devices

FDA 510(k) Submission Details - K012226

510(k) Number K012226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date April 08, 2002
Days to Decision 266 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
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 322
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K012226.
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE
K021279 · Datex-Ohmeda · Jul 2002
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
K021422 · Philips Medical Systems · May 2002
MODIFICATION OF APEXPRO TELEMETRY SYSTEM
K021325 · General Electric Medical Systems Information Techn · May 2002
DINAMAP PRO 1000 MONITOR, MODEL 1000
K012915 · Ge Medical Systems Information Technologies · Mar 2002
PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A
K020531 · Philips Medical Systems · Mar 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
K014261 · Philips Medical Systems, Inc. · Feb 2002