Cleared Traditional

K851473 - VYGON DELEE SUCTION CATHETER CODE NO 533

K851473 is an FDA 510(k) clearance for VYGON DELEE SUCTION CATHETER CODE NO 533, manufactured by Vygon Corp.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K851473 · Vygon Corp. · Anesthesiology device
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Jul 1985
Decision
91d
Days
Class 1
Risk

K851473 is an FDA 510(k) clearance for the VYGON DELEE SUCTION CATHETER CODE NO 533. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Vygon Corp. (East Rutherford, US). The FDA issued a Cleared decision on July 15, 1985 after a review of 91 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.

View all Vygon Corp. devices

FDA 510(k) Submission Details - K851473

510(k) Number K851473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1985
Decision Date July 15, 1985
Days to Decision 91 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
49d faster than avg
Panel avg: 140d · This submission: 91d
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 53
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K851473.
TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110
K864535 · Concord Laboratories, Inc. · Jan 1987
TRACHEOBRONCHIAL SUCTION CATHETER
K860802 · Sheridan Catheter Corp. · Apr 1986
ACKRAD ORAL SUCTION TUBE
K854320 · Ackrad Laboratories · Jan 1986
BRONCHITRAC L
K850784 · Ackrad Laboratories · Mar 1985
SUCTION CATHETER KIT
K843076 · Travenol Laboratories, S.A. · Nov 1984
JINOTTI OXYGEN/SUCTION CATHETER
K841425 · Research Medical, Inc. · Sep 1984