Cleared Traditional

K934639 - JOBST ATHROMBIC PUMP - SYSTEM 2500

K934639 is an FDA 510(k) clearance for JOBST ATHROMBIC PUMP - SYSTEM 2500, manufactured by Jobst Institute, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K934639 · Jobst Institute, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
133d
Days
Class 2
Risk

K934639 is an FDA 510(k) clearance for the JOBST ATHROMBIC PUMP - SYSTEM 2500. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Jobst Institute, Inc. (Charlotte, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 133 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.

View all Jobst Institute, Inc. devices

FDA 510(k) Submission Details - K934639

510(k) Number K934639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1993
Decision Date February 09, 1994
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
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 271
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K934639.
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INTERMITTENT COMPRESSION SYSTEM MODEL 5000
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SCD(R) CONTROLLER
K933259 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1993
KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICE
K932835 · Kendall Healthcare Products Co. Div.Of Tyco Health · Aug 1993