Cleared Traditional

K881833 - NASAL CPAP SYSTEM

K881833 is an FDA 510(k) clearance for NASAL CPAP SYSTEM, manufactured by Healthdyne, Inc.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K881833 · Healthdyne, Inc. · Anesthesiology device
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Jun 1988
Decision
56d
Days
Class 2
Risk

K881833 is an FDA 510(k) clearance for the NASAL CPAP SYSTEM. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Marietta, US). The FDA issued a Cleared decision on June 24, 1988 after a review of 56 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 Healthdyne, Inc. devices

FDA 510(k) Submission Details - K881833

510(k) Number K881833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1988
Decision Date June 24, 1988
Days to Decision 56 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
84d faster than avg
Panel avg: 140d · This submission: 56d
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 K881833.
EDENTEC MODEL 2860 PRESSURE METER
K891540 · Edentec Corp. · Jun 1989
MODIFIED SANDERS BI-PAPEASY
K883825 · Respironics, Inc. · Dec 1988
P.E.E.P. VALVE
K882219 · Life Support Products, Inc. · Aug 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
ARIES
K873170 · Mountain Medical Equipment, Inc. · Sep 1987