Cleared Traditional

K911080 - HYGIENA-TRACH

K911080 is an FDA 510(k) clearance for HYGIENA-TRACH, manufactured by Apdyne Medical Co.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K911080 · Apdyne Medical Co. · Anesthesiology device
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May 1991
Decision
70d
Days
Class 2
Risk

K911080 is an FDA 510(k) clearance for the HYGIENA-TRACH. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Apdyne Medical Co. (Saint Paul, US). The FDA issued a Cleared decision on May 20, 1991 after a review of 70 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.

FDA 510(k) Submission Details - K911080

510(k) Number K911080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date May 20, 1991
Days to Decision 70 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 140d · This submission: 70d
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 102
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K911080.
BIVONA CUFF MAINTENANCE DEVICE (CMD)
K914183 · Bivona Medical Technologies · Oct 1991
BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
K913270 · Bivona Medical Technologies · Aug 1991
BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.
K912967 · Bivona Medical Technologies · Jul 1991
TRACHEOSTOMY CARE KIT
K910362 · Megadyne Medical Products, Inc. · Apr 1991
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K903435 · Shiley, Inc. · Oct 1990
HOOD SPEAKING VALVE
K897059 · Hood Laboratories · Mar 1990
K911080 · HYGIENA-TRACH
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