Cleared Special

MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD (K093308) - FDA 510(k) Clearance

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

K093308 · Nidek Medical Products, Inc. · Anesthesiology device
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Jan 2010
Decision
84d
Days
Class 2
Risk

K093308 is an FDA 510(k) clearance for the MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on January 14, 2010 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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 Nidek Medical Products, Inc. devices

Submission Details

510(k) Number K093308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2009
Decision Date January 14, 2010
Days to Decision 84 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 139d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 285
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