Cleared Traditional

K921562 - JOBST EXTREMITY PUMP SYSTEM 7500

K921562 is an FDA 510(k) clearance for JOBST EXTREMITY PUMP SYSTEM 7500, 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 82-day FDA review.

K921562 · Jobst Institute, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
82d
Days
Class 2
Risk

K921562 is an FDA 510(k) clearance for the JOBST EXTREMITY PUMP SYSTEM 7500. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Jobst Institute, Inc. (Toledo, US). The FDA issued a Cleared decision on June 22, 1992 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jobst Institute, Inc. devices

FDA 510(k) Submission Details - K921562

510(k) Number K921562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1992
Decision Date June 22, 1992
Days to Decision 82 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
43d faster than avg
Panel avg: 125d · This submission: 82d
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 K921562.
COWBOY III
K932215 · Kinetic Concepts, Inc. · Jul 1993
PRESSSION, SEQUENTIAL
K921608 · Chattanooga Group, Inc. · Dec 1992
COWBOY II
K920308 · Kinetic Concepts, Inc. · Aug 1992
COWBOY
K913611 · Kinetic Concepts, Inc. · Jan 1992
PULSATILE ANTI-EMBOLISM SYS.PUMP
K911853 · Baxter Healthcare Corp · Jul 1991
FLOWPLUS AC330 PUMP GARMENTS
K910188 · Huntleigh Technology, Inc. · May 1991