Cleared Traditional

K850105 - KM PRODUCTS ASPIRATING TUBING

K850105 is an FDA 510(k) clearance for KM PRODUCTS ASPIRATING TUBING, manufactured by Km Products. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K850105 · Km Products · Anesthesiology device
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Mar 1985
Decision
69d
Days
Class 1
Risk

K850105 is an FDA 510(k) clearance for the KM PRODUCTS ASPIRATING TUBING. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Km Products (Tucson, US). The FDA issued a Cleared decision on March 21, 1985 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Km Products devices

FDA 510(k) Submission Details - K850105

510(k) Number K850105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1985
Decision Date March 21, 1985
Days to Decision 69 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 140d · This submission: 69d
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 70
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K850105.
ACKRAD ORAL SUCTION TUBE
K854320 · Ackrad Laboratories · Jan 1986
VYGON DELEE SUCTION CATHETER CODE NO 533
K851473 · Vygon Corp. · Jul 1985
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
AMER. PHARMASEAL NO TOUCH SATIN CATHET
K842198 · American Pharmaseal Div. Ahsc · Jun 1984