Cleared Traditional

K954489 - TRINITY SLEEVE(S)

K954489 is an FDA 510(k) clearance for TRINITY SLEEVE(S), 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 148-day FDA review.

K954489 · Delphi Consulting Group · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
148d
Days
Class 2
Risk

K954489 is an FDA 510(k) clearance for the TRINITY SLEEVE(S). 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 February 22, 1996 after a review of 148 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K954489

510(k) Number K954489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1995
Decision Date February 22, 1996
Days to Decision 148 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
23d slower than avg
Panel avg: 125d · This submission: 148d
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 343
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K954489.
M.I.C.
K950967 · V.V.T. Healthcare Technologies, Inc. · May 1996
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A-V IMPULSE SYSTEM MODEL 6060
K951683 · Novamedix , Ltd. · Oct 1995
AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM)
K951684 · Digital Air Corp. · Oct 1995
K954489 · TRINITY SLEEVE(S)
Download PDF FDA Summary Delphi Consulting Gro…