Cleared Traditional

REINFORCED SILICONE TRACHEAL TUBE (K830352) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830352 · Portex, Inc. · Anesthesiology device

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Mar 1983

Decision

33d

Days

Class 2

Risk

K830352 is an FDA 510(k) clearance for the REINFORCED SILICONE TRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Portex, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1983 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 Portex, Inc. devices

Submission Details

510(k) Number	K830352 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 03, 1983
Decision Date	March 08, 1983
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

107d faster than avg

Panel avg: 140d · This submission: 33d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	BTR Tube, Tracheal (w/wo Connector)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 868.5730

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 - BTR Tube, Tracheal (w/wo Connector)

All 40

Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K830352.

DOUBLE CONTOURED CUFF TRACHEAL TUBE

K843714 · Ohmeda Medical · Oct 1984

3-DAY BIOINDICATOR RELEASE FOR STERIL

K833831 · Shiley, Inc. · Mar 1984

ARGYLE JET TRACHEAL TUBE

K833807 · Sherwood Medical Co. · Jan 1984

ARGYLE TARTAN I TRACHEAL TUBE

K821670 · Sherwood Medical Co. · Jun 1982

TRACELON

K821180 · Terumo Medical Corp. · May 1982

SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL

K821027 · Shiley, Inc. · May 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K830352

Portex, Inc.

Mchenry, IL · US

Regulatory profile

20 submissions 20 cleared

100% clearance rate · Active in Anesthesiology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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