Cleared Traditional

PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS (K924337) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924337 · Deknatel, Inc. · General Hospital
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Jul 1993
Decision
335d
Days
Class 2
Risk

K924337 is an FDA 510(k) clearance for the PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Deknatel, Inc. (San Jose-Heredia, CR). The FDA issued a Cleared decision on July 28, 1993 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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. Elevated predicate reliance profile. 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.

View all Deknatel, Inc. devices

Submission Details

510(k) Number K924337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1992
Decision Date July 28, 1993
Days to Decision 335 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 129d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 14
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K924337.
CODMAN SUCTION PATTIE
K901937 · Codman & Shurtleff, Inc. · Jul 1990
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
K893741 · Abbott Laboratories · Aug 1989
RECEPTAL SAF-GARD(TM) SYSTEM
K885208 · Abbott Laboratories · Mar 1989
VAC-RITE
K885334 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1989
OHMEDA POSI-PULSE SUCTION UNIT
K861261 · Ohmeda Medical · May 1986
PLEUR-EVAC A-4005 SYSTEM
K823037 · Howmedica Corp. · Oct 1982