Cleared Traditional

K940615 - ACCUTEST (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K940615 · Instrumed, Inc. · General & Plastic Surgery device
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May 1995
Decision
459d
Days
Class 1
Risk

K940615 is an FDA 510(k) clearance for the ACCUTEST. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Instrumed, Inc. (Bothell, US). The FDA issued a Cleared decision on May 19, 1995 after a review of 459 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Instrumed, Inc. devices

Submission Details

510(k) Number K940615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1994
Decision Date May 19, 1995
Days to Decision 459 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
345d slower than avg
Panel avg: 114d · This submission: 459d
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.