Cleared Traditional

K071040 - WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS

K071040 is an FDA 510(k) clearance for WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPR..., manufactured by Wright Linear Pump, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K071040

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

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ROBERT MOSENKIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 269
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