Cleared Traditional

NormaTec PCD-T and PCD-B (K161346) - FDA 510(k) Clearance

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

K161346 · NormaTec Industries, LP · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2016
Decision
30d
Days
Class 2
Risk

K161346 is an FDA 510(k) clearance for the NormaTec PCD-T and PCD-B. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by NormaTec Industries, LP (Newton, US). The FDA issued a Cleared decision on June 15, 2016 after a review of 30 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 NormaTec Industries, LP devices

Submission Details

510(k) Number K161346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2016
Decision Date June 15, 2016
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 92
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K161346.
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