Cleared Traditional

K812302 - SHILEY FENESTRATED LOW PRESS. CUFFED

K812302 is an FDA 510(k) clearance for SHILEY FENESTRATED LOW PRESS. CUFFED, manufactured by Shiley, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K812302 · Shiley, Inc. · Anesthesiology device
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Sep 1981
Decision
25d
Days
Class 2
Risk

K812302 is an FDA 510(k) clearance for the SHILEY FENESTRATED LOW PRESS. CUFFED. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 8, 1981 after a review of 25 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 - K812302

510(k) Number K812302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1981
Decision Date September 08, 1981
Days to Decision 25 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
115d faster than avg
Panel avg: 140d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOH Device Classification - Class 2, Special Controls

Product Code JOH Tube Tracheostomy And Tube Cuff
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 - JOH Tube Tracheostomy And Tube Cuff

All 60
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K812302.
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K890194 · Shiley, Inc. · Jul 1989
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K885129 · Bivona Medical Technologies · Feb 1989
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K885130 · Bivona Medical Technologies · Feb 1989
REGULATOR, PRESSURE, CUFF
K760453 · Boehringer Laboratories · Sep 1976