Cleared Special

K113596 - MASIMO SET REUSABLE OXIMETRY SENSORS

K113596 is an FDA 510(k) clearance for MASIMO SET REUSABLE OXIMETRY SENSORS, manufactured by Masimo Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 81-day FDA review.

K113596 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
81d
Days
Class 2
Risk

K113596 is an FDA 510(k) clearance for the MASIMO SET REUSABLE OXIMETRY SENSORS. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on February 24, 2012 after a review of 81 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 Masimo Corporation devices

FDA 510(k) Submission Details - K113596

510(k) Number K113596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2011
Decision Date February 24, 2012
Days to Decision 81 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
59d faster than avg
Panel avg: 140d · This submission: 81d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K113596.
E1 EAR SENSORS
K121912 · Masimo Corporation · Jul 2012
NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM
K120773 · Covidien, LLC · Jul 2012
PULSE OXIMETER
K112843 · Nonin Medical, Inc. · Apr 2012
FINGERTIP PULSE OXIMETER
K112804 · Guangdong Biolight Meditech Co., Ltd. · Jan 2012
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