Cleared Traditional

3-DAY BIOINDICATOR RELEASE FOR RESPIR (K833832) - FDA 510(k) Clearance

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

K833832 · Shiley, Inc. · Anesthesiology device
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Mar 1984
Decision
129d
Days
Class 2
Risk

K833832 is an FDA 510(k) clearance for the 3-DAY BIOINDICATOR RELEASE FOR RESPIR. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1984 after a review of 129 days - within the typical 510(k) review window.

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: 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 K833832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1983
Decision Date March 15, 1984
Days to Decision 129 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
11d faster than avg
Panel avg: 140d · This submission: 129d
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 21
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K833832.
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
K865061 · Shiley, Inc. · Jan 1987
SHILEY DISPOS. CANNULA FENESTRATED LOW
K843729 · Shiley, Inc. · Oct 1984
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730 · Shiley, Inc. · Oct 1984
DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY
K840539 · Shiley, Inc. · Mar 1984
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW
K831720 · Sherwood Medical Co. · Jul 1983
SHILEY DISPOSABLE CANNULA TRACH. TUBE
K811447 · Shiley, Inc. · Jun 1981