Cleared Traditional

K843748 - ANTI-ASPIRATION VALVE

K843748 is an FDA 510(k) clearance for ANTI-ASPIRATION VALVE, manufactured by Travenol Laboratories, S.A.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K843748 · Travenol Laboratories, S.A. · General Hospital
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Jan 1985
Decision
100d
Days
Class 2
Risk

K843748 is an FDA 510(k) clearance for the ANTI-ASPIRATION VALVE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1985 after a review of 100 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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.

FDA 510(k) Submission Details - K843748

510(k) Number K843748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1984
Decision Date January 03, 1985
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 1173
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K843748.
ARTERIAL EXTENSION SET
K850088 · Medical Matrix, Inc. · Feb 1985
FLOW MED SK 140 BURET
K844820 · D.R.O. Medical, Inc. · Jan 1985
IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI
K844937 · Y · Jan 1985
GENT-L-KARE STERILE I.V. START KIT
K844255 · Geneva Laboratories, Inc. · Dec 1984
UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM
K843090 · Geneva Laboratories, Inc. · Dec 1984
FLU VEN I.V. SET 0153-C PERMA-SET
K843692 · Venusa , Ltd. · Oct 1984
K843748 · ANTI-ASPIRATION VALVE
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