Cleared Traditional

K811033 - SHILEY LOW PRESSURE THIN-CUFFED TRACH

K811033 is an FDA 510(k) clearance for SHILEY LOW PRESSURE THIN-CUFFED TRACH, manufactured by Shiley, Inc.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K811033 · Shiley, Inc. · Anesthesiology device
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May 1981
Decision
28d
Days
Class 2
Risk

K811033 is an FDA 510(k) clearance for the SHILEY LOW PRESSURE THIN-CUFFED TRACH. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Shiley, Inc. (Walker, US). The FDA issued a Cleared decision on May 13, 1981 after a review of 28 days - a notably fast clearance cycle.

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: 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K811033

510(k) Number K811033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1981
Decision Date May 13, 1981
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K811033.
CONTAINERS OF STERILE WATER OS SALINE
K822811 · American Pharmaseal Div. Ahsc · Oct 1982
SURGI TEK'S DISPOS. INNER CANNULA FOR
K822295 · Medical Engineering Corp. · Aug 1982
SHILEY DISPOSABLE CANNULA TRACH. TUBE
K811447 · Shiley, Inc. · Jun 1981
MONTGOMERY SILICONE TRACHEAL T-TUBE
K810978 · Boston Medical Products, Inc. · May 1981
TRACHEOSTOMA VENT
K810436 · Bivona Medical Technologies · Mar 1981
SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE
K810106 · Shiley, Inc. · Feb 1981