Cleared Traditional

K161346 - NormaTec PCD-T and PCD-B

K161346 is an FDA 510(k) clearance for NormaTec PCD-T and PCD-B, manufactured by NormaTec Industries, LP. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K161346 · NormaTec Industries, LP · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K161346

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.

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 121
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K161346.
Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
K163620 · Covidien · Jan 2017
Reprocessed Kendall SCD Express Foot Cuff
K163055 · Covidien · Dec 2016
Reprocessed Compression Garments
K161105 · Covidien · Aug 2016
REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES
K140813 · Covidien · Jul 2014
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K132360 · Covidien · Aug 2013
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K120944 · Covidien · May 2012