Cleared Traditional

K140430 - 740 SELECT

K140430 is an FDA 510(k) clearance for 740 SELECT, manufactured by Cas Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K140430 · Cas Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
114d
Days
Class 2
Risk

K140430 is an FDA 510(k) clearance for the 740 SELECT. 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 June 13, 2014 after a review of 114 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K140430

510(k) Number K140430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2014
Decision Date June 13, 2014
Days to Decision 114 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
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

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 253
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K140430.
VC150 VITAL SIGNS MONITOR
K133810 · Innokas Yhtyma · Oct 2014
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
K134014 · Remote Diagnostic Technologies , Ltd. · Aug 2014
MASIMO ROOT MONITORING SYSTEM
K140188 · Masimo Corporation · Jun 2014
HANDHELD MONITOR
K131762 · Guangdong Biolight Meditech Co., Ltd. · Jun 2014
VITAL SIGNS MONITOR
K132037 · Mindray North America · May 2014
TEMPUS PRO EXTENDED FEATURES
K133988 · Remote Diagnostic Technologies , Ltd. · May 2014