Cleared Traditional

K840539 - DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY

K840539 is an FDA 510(k) clearance for DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY, 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 30-day FDA review.

K840539 · Shiley, Inc. · Anesthesiology device
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Mar 1984
Decision
30d
Days
Class 2
Risk

K840539 is an FDA 510(k) clearance for the DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY. 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 9, 1984 after a review of 30 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 - K840539

510(k) Number K840539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1984
Decision Date March 09, 1984
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
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 K840539.
SHILEY DISPOS. CANNULA FENESTRATED LOW
K843729 · Shiley, Inc. · Oct 1984
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730 · Shiley, Inc. · Oct 1984
3-DAY BIOINDICATOR RELEASE FOR RESPIR
K833832 · Shiley, Inc. · Mar 1984
H.R. JAKOBI SURG. INSTRUMENTS #9 48
K834179 · Imm Enterprises , Ltd. · Jan 1984
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW
K831720 · Sherwood Medical Co. · Jul 1983
CONTAINERS OF STERILE WATER OS SALINE
K822811 · American Pharmaseal Div. Ahsc · Oct 1982