Cleared Traditional

K854320 - ACKRAD ORAL SUCTION TUBE

K854320 is an FDA 510(k) clearance for ACKRAD ORAL SUCTION TUBE, manufactured by Ackrad Laboratories. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K854320 · Ackrad Laboratories · Anesthesiology device
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Jan 1986
Decision
74d
Days
Class 1
Risk

K854320 is an FDA 510(k) clearance for the ACKRAD ORAL SUCTION TUBE. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Ackrad Laboratories (Cranford, US). The FDA issued a Cleared decision on January 10, 1986 after a review of 74 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 Ackrad Laboratories devices

FDA 510(k) Submission Details - K854320

510(k) Number K854320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date January 10, 1986
Days to Decision 74 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
66d faster than avg
Panel avg: 140d · This submission: 74d
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 K854320.
TRACHEOBRONCHIAL SUCTION CATHETER
K864468 · Sheridan Catheter Corp. · Jan 1987
TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110
K864535 · Concord Laboratories, Inc. · Jan 1987
TRACHEOBRONCHIAL SUCTION CATHETER
K860802 · Sheridan Catheter Corp. · Apr 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