Cleared Special

K023420 - PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB

K023420 is an FDA 510(k) clearance for PULSED OXYGEN CONSERVING DEVICE - EVERY..., manufactured by Medical Electronic Devices, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Special 510(k) pathway after a 14-day FDA review.

K023420 · Medical Electronic Devices, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K023420

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

NFB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NFB Conserver, Oxygen

All 62
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K023420.
EASY PULSE II OXYGEN CONSERVER
K032018 · Precision Medical, Inc. · Aug 2003
AIRLIFE DEMAND NASAL CANNULA
K023673 · Allegiance Healthcare Corp. · May 2003
6203
K022865 · Contemporary Products, Inc. · Feb 2003
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
K020475 · Chad Therapeutics, Inc. · Jul 2002
DEVILBISS PD1000
K020329 · Sunrise Medical Hhg, Inc. · Jun 2002
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830
K010747 · Western Ent. · May 2001