Cleared Traditional

K843076 - SUCTION CATHETER KIT

K843076 is an FDA 510(k) clearance for SUCTION CATHETER KIT, manufactured by Travenol Laboratories, S.A.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K843076 · Travenol Laboratories, S.A. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
106d
Days
Class 1
Risk

K843076 is an FDA 510(k) clearance for the SUCTION CATHETER KIT. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on November 20, 1984 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K843076

510(k) Number K843076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1984
Decision Date November 20, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 140d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

BSY Device Classification - Class 1, General Controls

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
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.

Regulatory Peers - BSY Catheters, Suction, Tracheobronchial

All 114
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K843076.
INTERMED, INS STERILE WATER/SALINE
K842166 · Intermed, Inc. · Feb 1985
A FAMILY OF TRACHEOBRONCHIAL SUCTION CATHETER PROD
K850032 · Paco Research Corp. · Feb 1985
STERILE SALINE SOLUTION
K843797 · Paco Pharmaceutical Services, Inc. · Jan 1985
ACT, SUCTION TIP
K842779 · Edward Manougian, M.D. · Oct 1984
JINOTTI OXYGEN/SUCTION CATHETER
K841425 · Research Medical, Inc. · Sep 1984
AMER. PHARMASEAL NO TOUCH SATIN CATHET
K842198 · American Pharmaseal Div. Ahsc · Jun 1984
K843076 · SUCTION CATHETER KIT
Download PDF Travenol Laboratories…