Cleared Traditional

K871693 - SLEEP APNEA NASAL CPAP SYSTEM

K871693 is an FDA 510(k) clearance for SLEEP APNEA NASAL CPAP SYSTEM, manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K871693 · Puritan Bennett Corp. · Anesthesiology device
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Sep 1987
Decision
139d
Days
Class 2
Risk

K871693 is an FDA 510(k) clearance for the SLEEP APNEA NASAL CPAP SYSTEM. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on September 15, 1987 after a review of 139 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K871693

510(k) Number K871693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1987
Decision Date September 15, 1987
Days to Decision 139 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
1d faster than avg
Panel avg: 140d · This submission: 139d
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 37
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K871693.
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
RESPIRONICS SANDERS BIPAPEASY
K871523 · Respironics, Inc. · Jul 1987
CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA
K861758 · Life Design Systems, Inc. · Jul 1986
LDS PEEP VALVE
K854822 · Life Design Systems, Inc. · Feb 1986