Cleared Special

K023420 - PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB (FDA 510(k) Clearance)

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

K023420 · Medical Electronic Devices, Inc. · Anesthesiology device
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Oct 2002
Decision
14d
Days
Class 2
Risk

K023420 is an FDA 510(k) clearance for the PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Medical Electronic Devices, Inc. (Torrance, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 14 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 Medical Electronic Devices, Inc. devices

Submission Details

510(k) Number K023420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2002
Decision Date October 25, 2002
Days to Decision 14 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
125d faster than avg
Panel avg: 139d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NFB Conserver, Oxygen
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.