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
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 38
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K983920.
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
K963347 · Instrumentation Industries, Inc. · Mar 1997
KENDALL SHERIDAN CPAP SYSTEM
K953511 · Kendall Healthcare Products Co. Div.Of Tyco Health · Oct 1995
SYSTEM 22 VALVE
K950397 · Turnkey Intergration USA, Inc. · Apr 1995
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