Cleared Special

K020730 - ORION NASAL CPAP SYSTEM

K020730 is an FDA 510(k) clearance for ORION NASAL CPAP SYSTEM, manufactured by Bird Products Corp.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 77-day FDA review.

K020730 · Bird Products Corp. · Anesthesiology device
Download Printable Device Report (PDF)
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May 2002
Decision
77d
Days
Class 2
Risk

K020730 is an FDA 510(k) clearance for the ORION NASAL CPAP SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Bird Products Corp. (Palm Spring, US). The FDA issued a Cleared decision on May 22, 2002 after a review of 77 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.

View all Bird Products Corp. devices

FDA 510(k) Submission Details - K020730

510(k) Number K020730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2002
Decision Date May 22, 2002
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
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 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K020730.
MIRAGE FULL FACE MASK SERIES 2
K023306 · Resmed, Ltd. · Nov 2002
IQ NASAL MASK, MODEL 50160 REV. D
K021534 · Sleepnet Corporation · Jul 2002
REMSTAR PRO WITH C-FLEX CPAP SYSTEM
K021861 · Respironics, Inc. · Jun 2002
REMSTAR AUTO CPAP SYSTEM
K012554 · Respironics, Inc. · Jan 2002
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