Cleared Traditional

K980456 - JOBST ATHROMBIC PUMP SYSTEM 2600

K980456 is an FDA 510(k) clearance for JOBST ATHROMBIC PUMP SYSTEM 2600, 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 89-day FDA review.

K980456 · Jobst A Beiersdorf Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
89d
Days
Class 2
Risk

K980456 is an FDA 510(k) clearance for the JOBST ATHROMBIC PUMP SYSTEM 2600. 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 May 5, 1998 after a review of 89 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 A Beiersdorf Co. devices

FDA 510(k) Submission Details - K980456

510(k) Number K980456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1998
Decision Date May 05, 1998
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 153
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K980456.
RTM DVT PROSOFT CUFF MODEL NUMBER PS100
K981643 · R.T. Medical Services, Inc. · Dec 1998
D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
K980600 · Dideco S.P.A. · Aug 1998
BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651
K971892 · Biomedical Horizons, Inc. · Aug 1998
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB
K974318 · Healthcare Service and Supply · Feb 1998
HUNTLEIGH FP5000 SYSTEM MODEL FP5000
K965153 · Huntleigh Healthcare, Inc. · Jan 1998
JOBST ATHROMBIC PUMP/SLEEVE
K970922 · Jobst A Beiersdorf Co. · Jan 1998