Cleared Traditional

K963929 - JOBST ATHROMBIC PUMP SYSTEM 2100

K963929 is an FDA 510(k) clearance for JOBST ATHROMBIC PUMP SYSTEM 2100, manufactured by Jobst A Beiersdorf Co.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K963929 · Jobst A Beiersdorf Co. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
144d
Days
Class 2
Risk

K963929 is an FDA 510(k) clearance for the JOBST ATHROMBIC PUMP SYSTEM 2100. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Jobst A Beiersdorf Co. (Charlotte, US). The FDA issued a Cleared decision on January 27, 1997 after a review of 144 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 - K963929

510(k) Number K963929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1996
Decision Date January 27, 1997
Days to Decision 144 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
19d slower than avg
Panel avg: 125d · This submission: 144d
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 K963929.
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K961405 · Alba-Waldensian, Inc. · Dec 1996
WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL
K961292 · Wright Linear Pump, Inc. · Nov 1996
K963929 · JOBST ATHROMBIC PUMP SYSTEM 2100
Download PDF FDA Summary Jobst A Beiersdorf Co.