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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 316
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K161346.
Intermittent Pneumatic Compression system
K160180 · Daesung Maref Co., Ltd. · Nov 2016
Reprocessed Compression Garments
K161105 · Covidien · Aug 2016
ActiveCare Home
K160431 · Medical Compression Systems (Dbn) , Ltd. · Jul 2016
Cirona 6400
K161209 · Devon Medical Products · May 2016
Venous Assist System
K150980 · Daesung Maref Co., Ltd. · May 2016
Hydroven 12, Hydroven 12 Garments
K152228 · Huntleigh Healthcare , Ltd. · Apr 2016