Cleared Traditional

K211140 - Reprocessed Masimo Pulse Oximeter (1859...

K211140 is an FDA 510(k) clearance for Reprocessed Masimo Pulse Oximeter (1859..., manufactured by Stryker Sustainability Solutions. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K211140 · Stryker Sustainability Solutions · Anesthesiology device
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Mar 2022
Decision
326d
Days
Class 2
Risk

K211140 is an FDA 510(k) clearance for the Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Mas.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on March 8, 2022 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K211140

510(k) Number K211140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2021
Decision Date March 08, 2022
Days to Decision 326 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
186d slower than avg
Panel avg: 140d · This submission: 326d
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 K211140.
Med-link Pulse Oximeter
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K211400 · Beijing Choice Electronic Technology Co., Ltd. · Feb 2022
Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
K211632 · Shenzhen Narig Bio-Medical Technology Co., Ltd. · Jan 2022