Cleared Special

K071285 - DIGITAL PULSE OXIMETER

K071285 is an FDA 510(k) clearance for DIGITAL PULSE OXIMETER, 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 66-day FDA review.

K071285 · Nonin Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
66d
Days
Class 2
Risk

K071285 is an FDA 510(k) clearance for the DIGITAL PULSE OXIMETER, MODEL 7500. 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 12, 2007 after a review of 66 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

FDA 510(k) Submission Details - K071285

510(k) Number K071285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2007
Decision Date July 12, 2007
Days to Decision 66 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
74d faster than avg
Panel avg: 140d · This submission: 66d
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
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K071285.
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
K072235 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2007
FINGERTIP PULSE OXIMETER MD300C
K070371 · Beijing Choice Electronic Technololgy Co., Ltd. · Aug 2007
DIGITAL PULSE OXIMETER, MODEL 7500FO
K071415 · Nonin Medical, Inc. · Aug 2007
MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
K071024 · Masimo Corporation · Jun 2007
DURAMAX REUSABLE OXIMETRY SENSOR
K070408 · Nellcor Puritan Bennett, Inc. · May 2007
LIFESENSE, MODEL LS1-9R
K063752 · Nonin Medical, Inc. · May 2007