Cleared Traditional

K142500 - One Way Soft Valve

K142500 is an FDA 510(k) clearance for One Way Soft Valve, manufactured by Terumo Cardiovascular Systems Corporation. The device is a Class 2 Cardiovascular device with product code MJJ cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K142500 · Terumo Cardiovascular Systems Corporation · Cardiovascular device
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Jan 2015
Decision
146d
Days
Class 2
Risk

K142500 is an FDA 510(k) clearance for the One Way Soft Valve. Classified as Cpb Check Valve, Retrograde Flow, In-line (product code MJJ), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corporation (Ashland, US). The FDA issued a Cleared decision on January 29, 2015 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 Terumo Cardiovascular Systems Corporation devices

FDA 510(k) Submission Details - K142500

510(k) Number K142500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2014
Decision Date January 29, 2015
Days to Decision 146 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
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJJ Device Classification - Class 2, Special Controls

Product Code MJJ Cpb Check Valve, Retrograde Flow, In-line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - MJJ Cpb Check Valve, Retrograde Flow, In-line

Devices cleared under the same product code (MJJ) and FDA review panel - the closest regulatory comparables to K142500.
MiniGuard Arterial Safety Valve
K182442 · Quest Medical, Inc. · Nov 2018
IBC FLOGUARD, MODEL 6050
K992785 · International Biophysics Corp. · Jan 2000
COBE VACUUM RELIEF CHECK VALVE
K982406 · Cobe Cardiovascular, Inc. · Oct 1998
SUCTION SAFETY DEVICE
K960937 · R D Intl. · Jun 1996
FLOW CONROL VALVE
K922781 · American Omni Medical, Inc. · Mar 1993
FLOW CONTROL VALVE, CAT. NO. ACV-38
K922356 · American Omni Medical, Inc. · Feb 1993