Cleared Traditional

K894050 - MODIFIED DECANNULATION STOPPER

K894050 is an FDA 510(k) clearance for MODIFIED DECANNULATION STOPPER, manufactured by Premier Medical. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K894050 · Premier Medical · Anesthesiology device
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Aug 1989
Decision
55d
Days
Class 2
Risk

K894050 is an FDA 510(k) clearance for the MODIFIED DECANNULATION STOPPER. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Premier Medical (Philadelphia, US). The FDA issued a Cleared decision on August 1, 1989 after a review of 55 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 Premier Medical devices

FDA 510(k) Submission Details - K894050

510(k) Number K894050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1989
Decision Date August 01, 1989
Days to Decision 55 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 140d · This submission: 55d
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 91
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K894050.
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K896548 · Bivona Medical Technologies · Jan 1990
BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894613 · Bivona Medical Technologies · Oct 1989
BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894614 · Bivona Medical Technologies · Oct 1989
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