Cleared Traditional

K904874 - ADJUSTABLE PEEP VALVE

K904874 is the FDA 510(k) clearance for ADJUSTABLE PEEP VALVE by Vital Signs, Inc.. It is a Class 2 Anesthesiology device (product code BYE) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K904874 · Vital Signs, Inc. · Anesthesiology device
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Jan 1991
Decision
70d
Days
Class 2
Risk

K904874 is an FDA 510(k) clearance for the ADJUSTABLE PEEP VALVE. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on January 8, 1991 after a review of 70 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K904874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1990
Decision Date January 08, 1991
Days to Decision 70 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
70d faster than avg
Panel avg: 140d · This submission: 70d
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 35
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K904874.
AMBU SINGLE PATIENT USE PEEP VALVE
K923976 · Ambu, Inc. · Jan 1993
COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION
K922178 · Puritan Bennett Corp. · May 1992
20CM/H20 PEEP VALVE
K912578 · Vital Signs, Inc. · Sep 1991
COMPANION 318 NASAL CPAP SYSTEM
K903764 · Puritan Bennett Corp. · Sep 1990
PEEP VALVE
K902062 · Hudson Oxygen Therapy Sales Co. · Sep 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE
K903125 · Puritan Bennett Corp. · Sep 1990