Cleared Traditional

K900548 - SHILEY PHONATION VALVE

K900548 is an FDA 510(k) clearance for SHILEY PHONATION VALVE, 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 77-day FDA review.

K900548 · Shiley, Inc. · Anesthesiology device
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Apr 1990
Decision
77d
Days
Class 2
Risk

K900548 is an FDA 510(k) clearance for the SHILEY PHONATION VALVE. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on April 23, 1990 after a review of 77 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 - K900548

510(k) Number K900548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1990
Decision Date April 23, 1990
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
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 K900548.
TRACHEOSTOMY CARE KIT
K921281 · Trinity Laboratories, Inc. · Aug 1992
BIVONA TRACHEAL T-TUBE STENT
K920604 · Bivona Medical Technologies · Jul 1992
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
K912469 · Bivona Medical Technologies · Jun 1991
TRACHEOSTOMY TRAY
K896798 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
HEIMLICH MICRO TRACH
K895130 · Ballard Medical Products · Nov 1989
SHILEY PERC TRACHEOSTOMY SYSTEM
K884730 · Shiley, Inc. · Jan 1989