Cleared Traditional

K974393 - VASO PRESS SYSTEM

K974393 is an FDA 510(k) clearance for VASO PRESS 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 483-day FDA review.

K974393 · Britt Corp., Inc. · Cardiovascular device
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Mar 1999
Decision
483d
Days
Class 2
Risk

K974393 is an FDA 510(k) clearance for the VASO PRESS SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Britt Corp., Inc. (Freehold, US). The FDA issued a Cleared decision on March 19, 1999 after a review of 483 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 - K974393

510(k) Number K974393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1997
Decision Date March 19, 1999
Days to Decision 483 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
358d slower than avg
Panel avg: 125d · This submission: 483d
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 282
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K974393.
WALKCARE P200 SYSTEM
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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