Cleared Traditional

K954788 - EUREDUC PNEUMATIC DRAINAGE SYSTEM

K954788 is an FDA 510(k) clearance for EUREDUC PNEUMATIC DRAINAGE SYSTEM, manufactured by Eureduc. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 376-day FDA review.

K954788 · Eureduc · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
376d
Days
Class 2
Risk

K954788 is an FDA 510(k) clearance for the EUREDUC PNEUMATIC DRAINAGE SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Eureduc (Antony, FR). The FDA issued a Cleared decision on October 28, 1996 after a review of 376 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Eureduc devices

FDA 510(k) Submission Details - K954788

510(k) Number K954788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1995
Decision Date October 28, 1996
Days to Decision 376 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
251d slower than avg
Panel avg: 125d · This submission: 376d
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 246
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K954788.
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
FLOWTRON EXCEL PUMP
K961166 · Hne Healthcare, Inc. · Oct 1996
EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03
K960902 · Eureduc · Sep 1996
HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM
K955853 · Healthcare Service and Supply · Jun 1996