Cleared Traditional

K963957 - TRINITY DVT SYSTEM

K963957 is an FDA 510(k) clearance for TRINITY DVT SYSTEM, manufactured by Delphi Consulting Group. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 398-day FDA review.

K963957 · Delphi Consulting Group · Cardiovascular device
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Nov 1997
Decision
398d
Days
Class 2
Risk

K963957 is an FDA 510(k) clearance for the TRINITY DVT SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Delphi Consulting Group (Houston, US). The FDA issued a Cleared decision on November 4, 1997 after a review of 398 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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. Elevated predicate reliance profile. 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 Delphi Consulting Group devices

FDA 510(k) Submission Details - K963957

510(k) Number K963957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1996
Decision Date November 04, 1997
Days to Decision 398 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
273d slower than avg
Panel avg: 125d · This submission: 398d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 - JOW Sleeve, Limb, Compressible

All 154
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K963957.
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB
K974318 · Healthcare Service and Supply · Feb 1998
HUNTLEIGH FP5000 SYSTEM MODEL FP5000
K965153 · Huntleigh Healthcare, Inc. · Jan 1998
JOBST ATHROMBIC PUMP/SLEEVE
K970922 · Jobst A Beiersdorf Co. · Jan 1998
TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)
K970014 · Delphi Consulting Group · Aug 1997
A-V IMPULSE SYSTEM MODEL 6060
K964425 · Powell,Goldstein,Frazer & Murphy · Jul 1997
SOF. PRESS EPC 51 SYSTEM
K963067 · Gaymar Industries, Inc. · Jan 1997