Cleared Traditional

K882219 - P.E.E.P. VALVE

K882219 is an FDA 510(k) clearance for P.E.E.P. VALVE, manufactured by Life Support Products, Inc.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K882219 · Life Support Products, Inc. · Anesthesiology device
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Aug 1988
Decision
96d
Days
Class 2
Risk

K882219 is an FDA 510(k) clearance for the P.E.E.P. VALVE. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Life Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on August 30, 1988 after a review of 96 days - within the typical 510(k) review window.

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 Life Support Products, Inc. devices

FDA 510(k) Submission Details - K882219

510(k) Number K882219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1988
Decision Date August 30, 1988
Days to Decision 96 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
44d faster than avg
Panel avg: 140d · This submission: 96d
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 46
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K882219.
DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM
K893388 · Devilbiss Health Care, Inc. · Jun 1989
EDENTEC MODEL 2860 PRESSURE METER
K891540 · Edentec Corp. · Jun 1989
MODIFIED SANDERS BI-PAPEASY
K883825 · Respironics, Inc. · Dec 1988
NASAL CPAP SYSTEM
K881833 · Healthdyne, Inc. · Jun 1988
MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)
K881614 · Ohmeda Medical · Apr 1988
ACKRAD PEDIATRIC C.P.A.P. SYSTEM
K880161 · Ackrad Laboratories · Mar 1988