Cleared Traditional

K840206 - PRESSURE SENTRY TOURNIQUET (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K840206 · Richards Medical Co., Inc. · General & Plastic Surgery device
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Apr 1984
Decision
97d
Days
Class 1
Risk

K840206 is an FDA 510(k) clearance for the PRESSURE SENTRY TOURNIQUET. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Richards Medical Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 97 days - within the typical 510(k) review window.

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.

View all Richards Medical Co., Inc. devices

Submission Details

510(k) Number K840206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1984
Decision Date April 25, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 114d · This submission: 97d
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.