Cleared Traditional

K024023 - ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER

K024023 is an FDA 510(k) clearance for ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ..., manufactured by Essex Medical Systems Plus. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K024023 · Essex Medical Systems Plus · Anesthesiology device
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Oct 2003
Decision
300d
Days
Class 2
Risk

K024023 is an FDA 510(k) clearance for the ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Essex Medical Systems Plus (Great Neck, US). The FDA issued a Cleared decision on October 1, 2003 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Essex Medical Systems Plus devices

FDA 510(k) Submission Details - K024023

510(k) Number K024023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2002
Decision Date October 01, 2003
Days to Decision 300 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 140d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 47
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K024023.
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
K042142 · Chad Therapeutics, Inc. · Sep 2004
EOCD
K041568 · Respironics, Inc. · Jul 2004
CHAD THERAPEUTICS SAGE
K033364 · Chad Therapeutics, Inc. · May 2004
EASY PULSE II OXYGEN CONSERVER
K032018 · Precision Medical, Inc. · Aug 2003
AIRLIFE DEMAND NASAL CANNULA
K023673 · Allegiance Healthcare Corp. · May 2003
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
K020475 · Chad Therapeutics, Inc. · Jul 2002