Cleared Special

K024300 - MICROCAP PLUS/NPB-75

K024300 is the FDA 510(k) clearance for MICROCAP PLUS/NPB-75 by Oridion Medical 1987 , Ltd.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Special 510(k) pathway after a 100-day FDA review.

K024300 · Oridion Medical 1987 , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
100d
Days
Class 2
Risk

K024300 is an FDA 510(k) clearance for the MICROCAP PLUS/NPB-75. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Oridion Medical 1987 , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on April 3, 2003 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Oridion Medical 1987 , Ltd. devices

Submission Details

510(k) Number K024300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2002
Decision Date April 03, 2003
Days to Decision 100 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
40d faster than avg
Panel avg: 140d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 369
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