Cleared Traditional

K222019 - Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K222019 · Stryker Sustainability Solutions · Anesthesiology device
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Dec 2022
Decision
149d
Days
Class 2
Risk

K222019 is an FDA 510(k) clearance for the Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt P.... Classified as Oximeter, Reprocessed (product code NLF), Class II - Special Controls.

Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on December 4, 2022 after a review of 149 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 Stryker Sustainability Solutions devices

Submission Details

510(k) Number K222019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2022
Decision Date December 04, 2022
Days to Decision 149 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
10d slower than avg
Panel avg: 139d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NLF Oximeter, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
Definition Same As Dqa Except Reprocessed. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05245526 Completed Interventional Industry-sponsored

SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor

Validate SpO2 Accuracy of Noninvasive Stryker Disposable Pulse Oximeter Sensors With Hypoxia at Rest

12
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Healthy; Hypoxia
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Philip E Bickler, MD, PhD
Sponsor Stryker Sustainability Solutions (industry)
Started 2022-01-19 → Primary completion 2022-01-20
Primary outcome
Accuracy of Sensor by Arms Calculation
View full study on ClinicalTrials.gov

Regulatory Peers - NLF Oximeter, Reprocessed

All 26
Devices cleared under the same product code (NLF) and FDA review panel - the closest regulatory comparables to K222019.
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000)
K241758 · Stryker Sustainability Solutions · Oct 2024
Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)
K211138 · Stryker Sustainability Solutions · Mar 2022