Cleared Traditional

K843889 - RESPIRONICS SLEEPEASY NASAL CPAP SYS

K843889 is an FDA 510(k) clearance for RESPIRONICS SLEEPEASY NASAL CPAP SYS, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K843889 · Respironics, Inc. · Anesthesiology device
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Dec 1984
Decision
63d
Days
Class 2
Risk

K843889 is an FDA 510(k) clearance for the RESPIRONICS SLEEPEASY NASAL CPAP SYS. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Respironics, Inc. (Monroeville, US). The FDA issued a Cleared decision on December 4, 1984 after a review of 63 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 Respironics, Inc. devices

FDA 510(k) Submission Details - K843889

510(k) Number K843889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1984
Decision Date December 04, 1984
Days to Decision 63 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
77d faster than avg
Panel avg: 140d · This submission: 63d
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 K843889.
CUSHION-FLEX TM-CPAP FACE MASK
K854458 · Life Design Systems, Inc. · Jan 1986
SANDER'S MASKCPAP BY RESPIRONICS
K851396 · Respironics, Inc. · May 1985
AMBU CPAP SYSTEM
K851194 · Ambu, Inc. · Apr 1985
OHMEDA PEEP VALVE FOR GMS ABSORBER
K843835 · Ohmeda Medical · Nov 1984
DRAGER PEEP SYSTEM D
K834085 · Draeger Medical, Inc. · Dec 1983
DOWNS ADJUSTABLE FLOW GENERATOR
K831503 · Vital Signs, Inc. · Sep 1983