Cleared Traditional

K051896 - MODEL 750E SERIES MONITOR

K051896 is the FDA 510(k) clearance for MODEL 750E SERIES MONITOR by Cas Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K051896 · Cas Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
156d
Days
Class 2
Risk

K051896 is an FDA 510(k) clearance for the MODEL 750E SERIES MONITOR. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on December 16, 2005 after a review of 156 days - an extended review cycle.

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: 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 Cas Medical Systems, Inc. devices

Submission Details

510(k) Number K051896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2005
Decision Date December 16, 2005
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 124
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K051896.
VS-800 VITAL SIGNS MONITOR
K063055 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2006
PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS
K053193 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2006
PM-9000 EXPRESS PATIENT MONITOR
K053234 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2006
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
K053027 · Welch Allyn, Inc. · Nov 2005
TRIO MONITOR
K051897 · Datascope Corp. · Aug 2005
UNITY NETWORK ID
K051518 · Ge Medical Systems Information Technologies · Jul 2005