Cleared Traditional

K100225 - PULSE OXIMETER MODEL P10

K100225 is the FDA 510(k) clearance for PULSE OXIMETER MODEL P10 by Mediana Co., Ltd.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K100225 · Mediana Co., Ltd. · Anesthesiology device
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Feb 2011
Decision
379d
Days
Class 2
Risk

K100225 is an FDA 510(k) clearance for the PULSE OXIMETER MODEL P10. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Mediana Co., Ltd. (Echo, US). The FDA issued a Cleared decision on February 9, 2011 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mediana Co., Ltd. devices

Submission Details

510(k) Number K100225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2010
Decision Date February 09, 2011
Days to Decision 379 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 140d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 369
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K100225.
MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS
K111621 · Masimo Corporation · Oct 2011
MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS
K111888 · Masimo Corporation · Sep 2011
MASIMO RADICAL Y PULSE CO-OXIMETER
K110028 · Masimo Corporation · Mar 2011
VITAL SIGNS MONITOR
K102835 · Edan Instruments, Inc. · Dec 2010
PULSE OXIMETER
K102350 · Nonin Medical, Inc. · Dec 2010
V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201
K101012 · Taidoc Technology Corporation · Dec 2010