Cleared Traditional

K961405 - ALBA HEALTH PAS WRAP SYSTEM

K961405 is an FDA 510(k) clearance for ALBA HEALTH PAS WRAP SYSTEM, manufactured by Alba-Waldensian, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K961405 · Alba-Waldensian, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
259d
Days
Class 2
Risk

K961405 is an FDA 510(k) clearance for the ALBA HEALTH PAS WRAP SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Alba-Waldensian, Inc. (Valdese, US). The FDA issued a Cleared decision on December 26, 1996 after a review of 259 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 Alba-Waldensian, Inc. devices

FDA 510(k) Submission Details - K961405

510(k) Number K961405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1996
Decision Date December 26, 1996
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
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 K961405.
SOF. PRESS EPC 51 SYSTEM
K963067 · Gaymar Industries, Inc. · Jan 1997
JOBST ATHROMBIC PUMP SYSTEM 2100
K963929 · Jobst A Beiersdorf Co. · Jan 1997
MODEL 90022 ROLLING STAND
K963672 · Augustine Medical, Inc. · Jan 1997
WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL
K961292 · Wright Linear Pump, Inc. · Nov 1996
WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE
K961797 · Wright Linear Pump, Inc. · Nov 1996
WLP SINGLE-SEGMENT VERSION WLP SOLO VII
K961891 · Wright Linear Pump, Inc. · Nov 1996