Cleared Traditional

K050918 - KOO AMERICAS VALVE PEEP, MODEL KM-809

K050918 is an FDA 510(k) clearance for KOO AMERICAS VALVE PEEP, manufactured by Koo Americas, Inc.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K050918 · Koo Americas, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
55d
Days
Class 2
Risk

K050918 is an FDA 510(k) clearance for the KOO AMERICAS VALVE PEEP, MODEL KM-809. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Koo Americas, Inc. (Alpharetta, US). The FDA issued a Cleared decision on June 6, 2005 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5965 - 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 - K050918

510(k) Number K050918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2005
Decision Date June 06, 2005
Days to Decision 55 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
85d faster than avg
Panel avg: 140d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYE Device Classification - Class 2, Special Controls

Product Code BYE Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5965
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 - BYE Attachment, Breathing, Positive End Expiratory Pressure

All 78
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K050918.
MERCURY MEDICAL PEEP VALVE
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BOUSSIGNAC C.P.A.P. DEVICE
K013884 · Vygon SA · Jan 2003
CPAP SYSTEM, MODEL 102001
K001318 · Sims Portex, Inc. · Jul 2000
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
K982283 · Caradyne, Ltd. · Mar 1999
K050918 · KOO AMERICAS VALVE PEEP, MODEL KM-809
Download PDF FDA Summary Koo Americas, Inc.