Cleared Special

K001930 - MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 (FDA 510(k) Clearance)

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

K001930 · Nonin Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
24d
Days
Class 2
Risk

K001930 is an FDA 510(k) clearance for the MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 20, 2000 after a review of 24 days - a notably fast clearance cycle.

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. 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 Nonin Medical, Inc. devices

Submission Details

510(k) Number K001930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2000
Decision Date July 20, 2000
Days to Decision 24 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
115d faster than avg
Panel avg: 139d · This submission: 24d
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 723
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K001930.
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