Cleared Traditional

K925243 - DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K925243 · Deknatel, Inc. · General & Plastic Surgery device
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Jul 1994
Decision
649d
Days
Class 1
Risk

K925243 is an FDA 510(k) clearance for the DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Deknatel, Inc. (San Jose-Heredia, CR). The FDA issued a Cleared decision on July 27, 1994 after a review of 649 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 878.4200 - 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 Deknatel, Inc. devices

Submission Details

510(k) Number K925243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1992
Decision Date July 27, 1994
Days to Decision 649 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
535d slower than avg
Panel avg: 114d · This submission: 649d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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.