Cleared Traditional

K983920 - EMS PEEP VALVES- ADJUSTABLE

K983920 is an FDA 510(k) clearance for EMS PEEP VALVES- ADJUSTABLE, manufactured by Engineered Medical Systems. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K983920 · Engineered Medical Systems · Anesthesiology device
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Jan 1999
Decision
79d
Days
Class 2
Risk

K983920 is an FDA 510(k) clearance for the EMS PEEP VALVES- ADJUSTABLE. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Engineered Medical Systems (Indianapolis, US). The FDA issued a Cleared decision on January 22, 1999 after a review of 79 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 Engineered Medical Systems devices

FDA 510(k) Submission Details - K983920

510(k) Number K983920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1998
Decision Date January 22, 1999
Days to Decision 79 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
61d faster than avg
Panel avg: 140d · This submission: 79d
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 67
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K983920.
BOUSSIGNAC C.P.A.P. DEVICE
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K981415 · Cheen Houng Ent. Co. , Ltd. · Jul 1998
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