Cleared Special

K090243 - REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K090243 · Respironics Inc., Sleep & Home Respiratory Group · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
95d
Days
Class 2
Risk

K090243 is an FDA 510(k) clearance for the REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Respironics Inc., Sleep & Home Respiratory Group (Murrysville, US). The FDA issued a Cleared decision on May 8, 2009 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Respironics Inc., Sleep & Home Respiratory Group devices

Submission Details

510(k) Number K090243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2009
Decision Date May 08, 2009
Days to Decision 95 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 139d · This submission: 95d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 456
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K090243.
F6S Full Face Mask (F6S)
K253166 · BMC Medical Co., Ltd. · Apr 2026
MySleepDash
K252338 · Somnetics International, Inc. (Dba Transcend Inc) · Apr 2026
Sleepnet Arie Full Face Vented Mask
K251847 · Sleepnet Corporation · Jan 2026
DeltaWave Nasal Pillow System
K253939 · RemSleep Holdings, Inc. · Jan 2026
SleepRes PAP System
K251770 · Sleepres, Inc. · Dec 2025
Personalized Therapy Comfort Settings (PTCS)
K251657 · ResMed Corp · Dec 2025