Cleared Traditional

K991038 - VASO PRESS DVT SYSTEM, MODELS VP500, VP501

K991038 is an FDA 510(k) clearance for VASO PRESS DVT SYSTEM, manufactured by Britt Corp., Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 451-day FDA review.

K991038 · Britt Corp., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
451d
Days
Class 2
Risk

K991038 is an FDA 510(k) clearance for the VASO PRESS DVT SYSTEM, MODELS VP500, VP501. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Britt Corp., Inc. (Colts Neck, US). The FDA issued a Cleared decision on June 22, 2000 after a review of 451 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Britt Corp., Inc. devices

FDA 510(k) Submission Details - K991038

510(k) Number K991038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date June 22, 2000
Days to Decision 451 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
326d slower than avg
Panel avg: 125d · This submission: 451d
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 281
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K991038.
VANGUARD REPROCESSED COMPRESSION GARMENT
K012403 · Vanguard Medical Concepts, Inc. · Oct 2001
VASO PRESS DVT FOOT GARMENT #VP 520
K003828 · Britt Corp., Inc. · May 2001
VENODYNE DVT ADVANTAGE MODEL 610
K001802 · Microtek Medical, Inc. · Jan 2001
PROAIR 3000 COMPRESSION SYSTEM
K993758 · Medical Compression Systems (Dbn) , Ltd. · May 2000
VENAFLOW SYSTEM, MODEL 30A
K992454 · Aircast, Inc. · Jan 2000
KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325
K992079 · The Kendall Company, L.P. · Sep 1999