Cleared Traditional

K102350 - PULSE OXIMETER

K102350 is an FDA 510(k) clearance for PULSE OXIMETER, manufactured by Nonin Medical, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K102350 · Nonin Medical, Inc. · Anesthesiology device
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Dec 2010
Decision
125d
Days
Class 2
Risk

K102350 is an FDA 510(k) clearance for the 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 December 22, 2010 after a review of 125 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nonin Medical, Inc. devices

FDA 510(k) Submission Details - K102350

510(k) Number K102350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2010
Decision Date December 22, 2010
Days to Decision 125 days
Submission Type Traditional
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
15d faster than avg
Panel avg: 140d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K102350.
MASIMO RADICAL Y PULSE CO-OXIMETER
K110028 · Masimo Corporation · Mar 2011
ESSENTIAL MRI PATIENT MONITOR
K103700 · Invivo Corporation · Mar 2011
VITAL SIGNS MONITOR
K102835 · Edan Instruments, Inc. · Dec 2010
V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201
K101012 · Taidoc Technology Corporation · Dec 2010
MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES
K101577 · Beijing Choice Electronic Technololgy Co., Ltd. · Dec 2010
VITAL SIGNS MONITOR MODEL M3B
K101539 · Edan Instruments, Inc. · Nov 2010