Cleared Traditional

K961797 - WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE

K961797 is an FDA 510(k) clearance for WLP GRADIENT SEQUENTIAL VERSION/WLP PRO..., manufactured by Wright Linear Pump, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K961797 · Wright Linear Pump, Inc. · Cardiovascular device
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Nov 1996
Decision
181d
Days
Class 2
Risk

K961797 is an FDA 510(k) clearance for the WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Wright Linear Pump, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on November 6, 1996 after a review of 181 days - an extended review cycle.

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.

View all Wright Linear Pump, Inc. devices

FDA 510(k) Submission Details - K961797

510(k) Number K961797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1996
Decision Date November 06, 1996
Days to Decision 181 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
56d slower than avg
Panel avg: 125d · This submission: 181d
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 269
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K961797.
MODEL 90022 ROLLING STAND
K963672 · Augustine Medical, Inc. · Jan 1997
ALBA HEALTH PAS WRAP SYSTEM
K961405 · Alba-Waldensian, Inc. · Dec 1996
WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL
K961292 · Wright Linear Pump, Inc. · Nov 1996
WLP SINGLE-SEGMENT VERSION WLP SOLO VII
K961891 · Wright Linear Pump, Inc. · Nov 1996
EUREDUC PNEUMATIC DRAINAGE SYSTEM
K954788 · Eureduc · Oct 1996
FLOWTRON EXCEL PUMP
K961166 · Hne Healthcare, Inc. · Oct 1996