Cleared Traditional

K133957 - DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE

K133957 is an FDA 510(k) clearance for DISPOSABLE ADJUSTABLE PEEP VALVE MR CON..., manufactured by Galemed Corp.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K133957 · Galemed Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
112d
Days
Class 2
Risk

K133957 is an FDA 510(k) clearance for the DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Galemed Corp. (Xiamen, Fujian, CN). The FDA issued a Cleared decision on April 14, 2014 after a review of 112 days - within the typical 510(k) review window.

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. 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 - K133957

510(k) Number K133957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2013
Decision Date April 14, 2014
Days to Decision 112 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
28d faster than avg
Panel avg: 140d · This submission: 112d
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 K133957.
Besmed PEEP Valve
K160112 · Besmed Health Business Corp · Apr 2016
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K133210 · S & T Medical Technologies, Inc. · Mar 2014
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
K122610 · Sen MU Technology Co., Ltd. · Aug 2013
O_TWO CPAP SYSTEM
K112546 · O-Two Medical Technologies, Inc. · Dec 2011
WATERPAP VALVE
K110713 · Airways Development, LLC · Sep 2011
NEOPIP PATIENT CIRCUIT WITH PEEP
K103833 · Neoforce Group, Inc. · Apr 2011