Cleared Traditional

K162365 - T-Cuff (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K162365 · Terumobct, Inc. · General & Plastic Surgery device
Feb 2017
Decision
177d
Days
Class 1
Risk

K162365 is an FDA 510(k) clearance for the T-Cuff. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Terumobct, Inc. (Lakewood, US). The FDA issued a Cleared decision on February 16, 2017 after a review of 177 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5910 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K162365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2016
Decision Date February 16, 2017
Days to Decision 177 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 132d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCY Tourniquet, Pneumatic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5910
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.