Cleared Traditional

K181956 - Masimo MightySat Rx Fingertip Pulse Oxi...

K181956 is an FDA 510(k) clearance for Masimo MightySat Rx Fingertip Pulse Oxi..., 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 184-day FDA review.

K181956 · Masimo Corporation · Anesthesiology device
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Jan 2019
Decision
184d
Days
Class 2
Risk

K181956 is an FDA 510(k) clearance for the Masimo MightySat Rx Fingertip Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on January 23, 2019 after a review of 184 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 - K181956

510(k) Number K181956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2018
Decision Date January 23, 2019
Days to Decision 184 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
44d slower than avg
Panel avg: 140d · This submission: 184d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K181956.
Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
K182822 · Taiwan Aulisa Medical Devices Technologies, Inc. · Mar 2019
Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
K183067 · Taiwan Aulisa Medical Devices Technologies, Inc. · Mar 2019
oCare Wrist Pulse Oximeter
K183556 · Taiwan Biophotonic Corporation · Feb 2019
vital signs monitor
K180380 · Edan Instruments, Inc. · Dec 2018
AS-3XX Series Fingertip Pulse Oximeter
K180685 · Xiamen Acurio Instruments Co., Ltd. · Nov 2018
Handheld Pulse Oximeter, Model SP-20
K172792 · Shenzhen Creative Industry Co., Ltd. · Nov 2018