Cleared Traditional

K945407 - SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT

K945407 is an FDA 510(k) clearance for SSVO PHONATE(TM) SHILEY SPEAKING VALVE ..., manufactured by Mallinckrodt Medical Tpi, Inc.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K945407 · Mallinckrodt Medical Tpi, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
116d
Days
Class 2
Risk

K945407 is an FDA 510(k) clearance for the SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Mallinckrodt Medical Tpi, Inc. (Irvine, US). The FDA issued a Cleared decision on February 27, 1995 after a review of 116 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mallinckrodt Medical Tpi, Inc. devices

FDA 510(k) Submission Details - K945407

510(k) Number K945407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1994
Decision Date February 27, 1995
Days to Decision 116 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 140d · This submission: 116d
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 73
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K945407.
CPR TRACHEOTOMY CARE TRAY
K960205 · Custom Pack Reliability · Aug 1996
MOORE TRACHEOSTOMY TUBE
K962240 · Boston Medical Products, Inc. · Aug 1996
LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
K953559 · Seidel Medizin GmbH · May 1996
LOW PROFILE TRACHEOSTOMY TUBE
K922749 · Concord/Portex · Sep 1992
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
K920281 · Trinity Laboratories, Inc. · Aug 1992
TRACHEOSTOMY CARE KIT
K921281 · Trinity Laboratories, Inc. · Aug 1992