Cleared Traditional

K944860 - SCHOLAR PATIENT MONITOR

K944860 is an FDA 510(k) clearance for SCHOLAR PATIENT MONITOR, manufactured by Criticare Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K944860 · Criticare Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
260d
Days
Class 2
Risk

K944860 is an FDA 510(k) clearance for the SCHOLAR PATIENT MONITOR. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Criticare Systems, Inc. (Waukesha, US). The FDA issued a Cleared decision on June 20, 1995 after a review of 260 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 Criticare Systems, Inc. devices

FDA 510(k) Submission Details - K944860

510(k) Number K944860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1994
Decision Date June 20, 1995
Days to Decision 260 days
Submission Type Traditional
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
135d slower than avg
Panel avg: 125d · This submission: 260d
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 321
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K944860.
DINAMAP COMPACT MONITOR
K970182 · Johnson & Johnson Medical, Inc. · Aug 1997
NPB-4000
K962424 · Analogic Corp. · Dec 1996
PARAMETERS MONITORES
K945099 · Ivy Biomedical Systems, Inc. · Jul 1995
DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340
K942700 · Critikon Company, LLC · Mar 1995
PORTABLE PATIENT MONITOR
K945134 · Hewlett-Packard Co. · Oct 1994
HEWLETT-PACKARD MODEL 78730 CAREVUE 5000
K922210 · Hewlett-Packard Co. · Apr 1993