Cleared Special

K090243 - REMSTAR M-SERIES AUTO WITH AFLEX CPAP S...

K090243 is an FDA 510(k) clearance for REMSTAR M-SERIES AUTO WITH AFLEX CPAP S..., manufactured by Respironics Inc., Sleep & Home Respiratory Group. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 95-day FDA review.

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

FDA 510(k) Submission Details - K090243

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 140d · This submission: 95d
Pathway characteristics
Modification to existing cleared device.

BZD Device Classification - Class 2, Special Controls

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 306
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K090243.
MINIME PEDIATRIC MASK
K090935 · Sleepnet Corporation · Jul 2009
RESPIRONICS PERFORMAX TOTAL FACE MASK
K091271 · Respironics Inc., Sleep & Home Respiratory Group · May 2009
RESPIRONICS SLEEPEASY CPAP SYSTEM
K091112 · Respironics, Inc. · May 2009
APEX MEDICAL XT AUTO CPAP 9S-005200
K083656 · Apex Medical Corp. · Apr 2009
SWIFT FX
K090244 · Resmed, Ltd. · Apr 2009
COMFORTLITE NASAL MASK
K082558 · Respironics, Inc. · Mar 2009