Cleared Special

K100617 - MASIMO RESPONSABLE OXIMETRY SENSORS MOD...

Also marketed or referenced as:
S2-20/20D

K100617 is an FDA 510(k) clearance for MASIMO RESPONSABLE OXIMETRY SENSORS MOD..., 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 85-day FDA review.

K100617 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
85d
Days
Class 2
Risk

K100617 is an FDA 510(k) clearance for the MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on May 28, 2010 after a review of 85 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 - K100617

510(k) Number K100617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2010
Decision Date May 28, 2010
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
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 K100617.
MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER
K100428 · Masimo Corporation · Jul 2010
MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
K100403 · Masimo Corporation · Jun 2010
SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
K093853 · Nonin Medical, Inc. · Jun 2010
HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M
K100203 · Beijing Choice Electronic Technololgy Co., Ltd. · May 2010
LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS
K094046 · Masimo Corporation · May 2010
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
K093881 · GE Healthcare Finland Oy · Mar 2010