Cleared Traditional

MODIFIED SANDERS BI-PAPEASY (K883825) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K883825 · Respironics, Inc. · Anesthesiology device
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Dec 1988
Decision
90d
Days
Class 2
Risk

K883825 is an FDA 510(k) clearance for the MODIFIED SANDERS BI-PAPEASY. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on December 8, 1988 after a review of 90 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 Respironics, Inc. devices

Submission Details

510(k) Number K883825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1988
Decision Date December 08, 1988
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 11
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K883825.
PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE
K903125 · Puritan Bennett Corp. · Sep 1990
RESPIRONICS' REMSTAR(TM) SLEEPEASY
K900113 · Respironics, Inc. · Mar 1990
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
K900164 · Puritan Bennett Corp. · Jan 1990
MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)
K881614 · Ohmeda Medical · Apr 1988
SLEEP APNEA NASAL CPAP SYSTEM
K871693 · Puritan Bennett Corp. · Sep 1987
RESPIRONICS SANDERS BIPAPEASY
K871523 · Respironics, Inc. · Jul 1987