Cleared Traditional

RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A (K111748) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K111748 · Joy Long · Cardiovascular device
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Nov 2011
Decision
154d
Days
Class 2
Risk

K111748 is an FDA 510(k) clearance for the RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Joy Long (Indianapolis, US). The FDA issued a Cleared decision on November 23, 2011 after a review of 154 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Joy Long devices

Submission Details

510(k) Number K111748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2011
Decision Date November 23, 2011
Days to Decision 154 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 349
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K111748.
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