Cleared Traditional

K101031 - MASIMO DISPOSABLE OXIMETRY EAR SENSOR

K101031 is an FDA 510(k) clearance for MASIMO DISPOSABLE OXIMETRY EAR SENSOR, manufactured by Masimo Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K101031 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
219d
Days
Class 2
Risk

K101031 is an FDA 510(k) clearance for the MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on November 18, 2010 after a review of 219 days - an extended review cycle.

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 Masimo Corporation devices

FDA 510(k) Submission Details - K101031

510(k) Number K101031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2010
Decision Date November 18, 2010
Days to Decision 219 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
79d slower than avg
Panel avg: 140d · This submission: 219d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K101031.
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
MASIMO LNCS/M-LNCS OXIMETRY SENSORS
K101896 · Masimo Corporation · Oct 2010
TRUSIGNAL SPO2 FINGERTIP SENSOR
K101871 · GE Healthcare Finland Oy · Oct 2010
HANDHELD PULSE OXIMETER MODEL M800
K101694 · Guangdong Biolight Meditech Co., Ltd. · Sep 2010