Cleared Traditional

K081266 - MERCURY MEDICAL PEEP VALVE

K081266 is an FDA 510(k) clearance for MERCURY MEDICAL PEEP VALVE, manufactured by Mercury Enterprizes Dba Mercury Medical. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K081266 · Mercury Enterprizes Dba Mercury Medical · Anesthesiology device
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Mar 2009
Decision
304d
Days
Class 2
Risk

K081266 is an FDA 510(k) clearance for the MERCURY MEDICAL PEEP VALVE. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Mercury Enterprizes Dba Mercury Medical (Clearwater, US). The FDA issued a Cleared decision on March 5, 2009 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K081266

510(k) Number K081266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2008
Decision Date March 05, 2009
Days to Decision 304 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 140d · This submission: 304d
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 69
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K081266.
VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
K092029 · Draeger Medical AG & Co. KG · Aug 2010
MERCURY CPAP
K090710 · Mercury Medical · Aug 2009
BABI*PLUS BUBBLE PAP VALVE
K090317 · A Plus Medical · May 2009
PULMODYNE CHF FLOW GENERATOR SYSTEM
K080256 · Pulmodyne · May 2008
NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP
K070416 · Neoforce Group, Inc. · May 2007
KOO AMERICAS VALVE PEEP, MODEL KM-809
K050918 · Koo Americas, Inc. · Jun 2005