Cleared Traditional

K782152 - VALVE

K782152 is an FDA 510(k) clearance for VALVE, manufactured by Narco Air-Shields. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway .

K782152 · Narco Air-Shields · Anesthesiology device
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Dec 1978
Decision
-
Days
Class 2
Risk

K782152 is an FDA 510(k) clearance for the VALVE, AMBU PEEP. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Narco Air-Shields (Houston, US). The FDA issued a Cleared decision on December 26, 1978.

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.

View all Narco Air-Shields devices

FDA 510(k) Submission Details - K782152

510(k) Number K782152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received December 26, 1978
Decision Date December 26, 1978
Days to Decision -
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
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 45
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K782152.
DRAGER PEEP CONTROL SYSTEM
K802707 · Draeger Medical, Inc. · Nov 1980
VITAL SIGNS PEEP VALVE
K802070 · Vital Signs, Inc. · Sep 1980
BOEHRINGER LABS AMBULATORY PEEP VALVE
K800755 · Boehringer Laboratories · May 1980
PEEP/CPAP VALVE
K781332 · Vickers America Medical Corp. · Oct 1978
VALVE, PEEP
K760230 · Ohio Medical Products · Aug 1976