Cleared Traditional

K073702 - PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR

K073702 is an FDA 510(k) clearance for PHONERIS INNER CANNULAE WITH PHONERIS A..., manufactured by Lazarus Medical, LLC. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K073702 · Lazarus Medical, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
178d
Days
Class 2
Risk

K073702 is an FDA 510(k) clearance for the PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Lazarus Medical, LLC (Raleigh, US). The FDA issued a Cleared decision on June 26, 2008 after a review of 178 days - an extended review 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: 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.

FDA 510(k) Submission Details - K073702

510(k) Number K073702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2007
Decision Date June 26, 2008
Days to Decision 178 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 140d · This submission: 178d
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 82
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K073702.
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
K100480 · Vitaltec Corporation · Jun 2010
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
K100283 · Cook, Inc. · Apr 2010
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
K083031 · Smiths Medical Asd, Inc. · Aug 2009
TALKING TRACH
K062104 · Engineered Medical Systems, Inc. · Apr 2007
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
K060945 · Smiths Medical International · Jun 2006
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
K051587 · Tracoe Medical GmbH · Oct 2005