Cleared Special

K080255 - NONIN MEDICAL

K080255 is an FDA 510(k) clearance for NONIN MEDICAL, manufactured by Nonin Medical, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 113-day FDA review.

K080255 · Nonin Medical, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
May 2008
Decision
113d
Days
Class 2
Risk

K080255 is an FDA 510(k) clearance for the NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 23, 2008 after a review of 113 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 Nonin Medical, Inc. devices

FDA 510(k) Submission Details - K080255

510(k) Number K080255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2008
Decision Date May 23, 2008
Days to Decision 113 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
27d faster than avg
Panel avg: 140d · This submission: 113d
Pathway characteristics
Modification to existing cleared device.

DQA Device Classification - Class 2, Special Controls

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 453
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