Cleared Traditional

K903125 - PURITAN BENNETT SINGLE PATIENT USE PEEP...

K903125 is an FDA 510(k) clearance for PURITAN BENNETT SINGLE PATIENT USE PEEP..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K903125 · Puritan Bennett Corp. · Anesthesiology device
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Sep 1990
Decision
50d
Days
Class 2
Risk

K903125 is an FDA 510(k) clearance for the PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on September 4, 1990 after a review of 50 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.

View all Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K903125

510(k) Number K903125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1990
Decision Date September 04, 1990
Days to Decision 50 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 140d · This submission: 50d
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 37
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K903125.
ADJUSTABLE PEEP VALVE
K904874 · Vital Signs, Inc. · Jan 1991
COMPANION 318 NASAL CPAP SYSTEM
K903764 · Puritan Bennett Corp. · Sep 1990
PEEP VALVE
K902062 · Hudson Oxygen Therapy Sales Co. · Sep 1990
ONE-LUNG CPAP DEVICE
K901728 · Vital Signs, Inc. · Aug 1990
RESPIRONICS' REMSTAR(TM) SLEEPEASY
K900113 · Respironics, Inc. · Mar 1990
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
K900164 · Puritan Bennett Corp. · Jan 1990