Cleared Traditional

K905448 - THORA-KLEX CHEST DRAINAGE UNIT

K905448 is an FDA 510(k) clearance for THORA-KLEX CHEST DRAINAGE UNIT, manufactured by Davol, Inc.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K905448 · Davol, Inc. · General Hospital
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Mar 1991
Decision
112d
Days
Class 2
Risk

K905448 is an FDA 510(k) clearance for the THORA-KLEX CHEST DRAINAGE UNIT. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on March 27, 1991 after a review of 112 days - within the typical 510(k) review window.

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. 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.

View all Davol, Inc. devices

FDA 510(k) Submission Details - K905448

510(k) Number K905448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1990
Decision Date March 27, 1991
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

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 57
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K905448.
PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS
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MODEL SLASE 210 HOLMIUM LASER SYSTEM
K920248 · Sunrise Technologies, Inc. · Jul 1992
COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM
K910377 · CooperSurgical, Inc. · Apr 1991
CODMAN SUCTION PATTIE
K901937 · Codman & Shurtleff, Inc. · Jul 1990
MANIFOLD
K896804 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
UNIVERSAL POOLE SUCTION TUBE
K896556 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990