Cleared Traditional

MONITORING SYSTEM,MODEL ARGUS PB-1000 (K012226) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 189
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K012226.
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
K023475 · Nihon Kohden America, Inc. · Oct 2002
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER
K022889 · Siemens Medical Solutions USA, Inc. · Sep 2002
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
K021422 · Philips Medical Systems · 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