Cleared Traditional

3-DAY BIOINDICATOR RELEASE FOR STERIL (K833831) - FDA 510(k) Clearance

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

K833831 · Shiley, Inc. · Anesthesiology device

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Mar 1984

Decision

135d

Days

Class 2

Risk

K833831 is an FDA 510(k) clearance for the 3-DAY BIOINDICATOR RELEASE FOR STERIL. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Shiley, Inc. (Walker, US). The FDA issued a Cleared decision on March 21, 1984 after a review of 135 days - within the typical 510(k) review window.

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: 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 Shiley, Inc. devices

Submission Details

510(k) Number	K833831 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 07, 1983
Decision Date	March 21, 1984
Days to Decision	135 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

5d faster than avg

Panel avg: 140d · This submission: 135d

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 39

Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K833831.

SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE

K861463 · Shiley, Inc. · May 1986

ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE

K844564 · Sherwood Medical Co. · Feb 1985

DOUBLE CONTOURED CUFF TRACHEAL TUBE

K843714 · Ohmeda Medical · Oct 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

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 K833831

Shiley, Inc.

Walker, MI · US

Regulatory profile

174 submissions 174 cleared

100% clearance rate · Active in Anesthesiology

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

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