Cleared Traditional

K071040 - WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPR...

K071040 is the FDA 510(k) clearance for WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPR... by Wright Linear Pump, Inc.. It is a Class 2 Cardiovascular device (product code JOW) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K071040 · Wright Linear Pump, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
40d
Days
Class 2
Risk

K071040 is an FDA 510(k) clearance for the WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Wright Linear Pump, Inc. (Oakdale, US). The FDA issued a Cleared decision on May 22, 2007 after a review of 40 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 Wright Linear Pump, Inc. devices

Submission Details

510(k) Number K071040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2007
Decision Date May 22, 2007
Days to Decision 40 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 125d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 115
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