Cleared Traditional

PERCUGUARD (K992539) - FDA 510(k) Clearance

Class I General Hospital device.

K992539 · Digit-Pro · General Hospital
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Feb 2000
Decision
203d
Days
Class 1
Risk

K992539 is an FDA 510(k) clearance for the PERCUGUARD. Classified as Finger Cot (product code LZB), Class I - General Controls.

Submitted by Digit-Pro (Houston, US). The FDA issued a Cleared decision on February 18, 2000 after a review of 203 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K992539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1999
Decision Date February 18, 2000
Days to Decision 203 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 129d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZB Finger Cot
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
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.