Cleared Traditional

K832466 - TRACHEAL TUBE 16 GAUGE-1.65MM-

K832466 is the FDA 510(k) clearance for TRACHEAL TUBE 16 GAUGE-1.65MM- by Erie Medical. It is a Class 2 Anesthesiology device (product code BTO) cleared through the Traditional 510(k) pathway after a 421-day FDA review.

K832466 · Erie Medical · Anesthesiology device
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Sep 1984
Decision
421d
Days
Class 2
Risk

K832466 is an FDA 510(k) clearance for the TRACHEAL TUBE 16 GAUGE-1.65MM-. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Erie Medical (Walker, US). The FDA issued a Cleared decision on September 19, 1984 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

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Submission Details

510(k) Number K832466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1983
Decision Date September 19, 1984
Days to Decision 421 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
281d slower than avg
Panel avg: 140d · This submission: 421d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BTO Tube, Tracheostomy (w/wo Connector)

All 24
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K832466.
LGT TUBE
K852413 · Mallinckrodt Critical Care · Sep 1985
SHILEY DISPOS. CANNULA FENESTRATED LOW
K843729 · Shiley, Inc. · Oct 1984
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730 · Shiley, Inc. · Oct 1984
3-DAY BIOINDICATOR RELEASE FOR RESPIR
K833832 · Shiley, Inc. · Mar 1984
DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY
K840539 · Shiley, Inc. · Mar 1984
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW
K831720 · Sherwood Medical Co. · Jul 1983