Cleared Traditional

K833831 - 3-DAY BIOINDICATOR RELEASE FOR STERIL

K833831 is an FDA 510(k) clearance for 3-DAY BIOINDICATOR RELEASE FOR STERIL, manufactured by Shiley, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 135-day FDA review.

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

FDA 510(k) Submission Details - K833831

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.

BTR Device Classification - Class 2, Special Controls

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 133
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K833831.
SHERIDAN/INTENSA TUBE
K842558 · Sheridan Catheter Corp. · Jul 1984
TRACHEAL TUBE/STETHOSCOPE
K842464 · Mallinckrodt Critical Care · Jul 1984
COLE TUBE-LATEX
K840973 · Inmed Corp. · Mar 1984
ARGYLE JET TRACHEAL TUBE
K833807 · Sherwood Medical Co. · Jan 1984
TRACH SWIVE/CONNECTOR
K833197 · Airlife, Inc. · Oct 1983
TRACHEAL TUBE W/ILLUMINATING LOCATER
K830631 · Mallinckrodt Critical Care · May 1983