Cleared Traditional

K111621 - MASIMO RESPOSABLE SPO2 SERIES OXIMETRY ...

K111621 is an FDA 510(k) clearance for MASIMO RESPOSABLE SPO2 SERIES OXIMETRY ..., 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 138-day FDA review.

K111621 · Masimo Corporation · Anesthesiology device
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Oct 2011
Decision
138d
Days
Class 2
Risk

K111621 is an FDA 510(k) clearance for the MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on October 26, 2011 after a review of 138 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 Masimo Corporation devices

FDA 510(k) Submission Details - K111621

510(k) Number K111621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2011
Decision Date October 26, 2011
Days to Decision 138 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
2d faster than avg
Panel avg: 140d · This submission: 138d
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 K111621.
HANDHELD PULSE OXIMETER
K111494 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2012
MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES
K111403 · Masimo Corporation · Dec 2011
VTRUST FINGER TYPE PULSE OXIMETER
K110893 · Taidoc Technology Corporation · Nov 2011
MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS
K111888 · Masimo Corporation · Sep 2011
TRUSIGNAL R SPO2 PEDITIP SENSOR
K103802 · GE Healthcare Finland Oy · Aug 2011
MASIMO RADICAL Y PULSE CO-OXIMETER
K110028 · Masimo Corporation · Mar 2011