Cleared Traditional

K843748 - ANTI-ASPIRATION VALVE

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

K843748 · Travenol Laboratories, S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Travenol Laboratories, S.A. devices

Submission Details

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.

Device Classification

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 448
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K843748.
MICRO VOLUME DOUBLE LINE EXTENSION SET
K850061 · Travenol Laboratories, S.A. · Mar 1985
CRITIKON I.V. ADMINISTRAION SET
K850507 · Critikon Company, LLC · Mar 1985
IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI
K844937 · Y · Jan 1985
MINISET VEIN INFUSION SETS
K843631 · Travenol Laboratories, S.A. · Oct 1984
IVAC C80014 Y SOLUTION ADMIN. SET
K843185 · Y · Sep 1984
FLUID ADMINISTRATION LINE W/SPIKE 14-923
K842858 · Norton Performance Plastics Corp. · Sep 1984