Cleared Special

K011229 - DEVILBISS 9000 SERIES CPAP, MODEL 9001

K011229 is an FDA 510(k) clearance for DEVILBISS 9000 SERIES CPAP, manufactured by Sunrise Medical Hhg, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 79-day FDA review.

K011229 · Sunrise Medical Hhg, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
79d
Days
Class 2
Risk

K011229 is an FDA 510(k) clearance for the DEVILBISS 9000 SERIES CPAP, MODEL 9001. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Sunrise Medical Hhg, Inc. (Somerset, US). The FDA issued a Cleared decision on July 11, 2001 after a review of 79 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K011229

510(k) Number K011229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2001
Decision Date July 11, 2001
Days to Decision 79 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
61d faster than avg
Panel avg: 140d · This submission: 79d
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 459
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K011229.
MINIME NASAL MASK, MODEL P/N 50220
K013306 · Sleepnet Corporation · Nov 2001
MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
K012034 · Sensor Medics Corp. · Jul 2001
ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530
K012207 · Tiara Medical Systems, Inc. · Jul 2001
BIPAP PRO BI-LEVEL SYSTEM
K011714 · Respironics, Inc. · Jun 2001
ORACLE ORAL MASK
K003894 · Fisher &Paykel Healthcare , Ltd. · Jun 2001
INFANT FLOW SYSTEM, MODEL M672P
K011516 · Eme (Electro Medical Equipment) , Ltd. · Jun 2001
K011229 · DEVILBISS 9000 SERIES CPAP, MODEL 9001
Download PDF FDA Summary Sunrise Medical Hhg, …