Cleared Traditional

AMBU SINGLE PATIENT USE PEEP VALVE (K923976) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923976 · Ambu, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
151d
Days
Class 2
Risk

K923976 is an FDA 510(k) clearance for the AMBU SINGLE PATIENT USE PEEP VALVE. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on January 5, 1993 after a review of 151 days - an extended review 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: 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 Ambu, Inc. devices

Submission Details

510(k) Number K923976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1992
Decision Date January 05, 1993
Days to Decision 151 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 140d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K923976.
COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION
K922178 · Puritan Bennett Corp. · May 1992
COMPANION 318 NASAL CPAP SYSTEM
K903764 · Puritan Bennett Corp. · Sep 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE
K903125 · Puritan Bennett Corp. · Sep 1990
RESPIRONICS' REMSTAR(TM) SLEEPEASY
K900113 · Respironics, Inc. · Mar 1990
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
K900164 · Puritan Bennett Corp. · Jan 1990
MODIFIED SANDERS BI-PAPEASY
K883825 · Respironics, Inc. · Dec 1988