Cleared Traditional

K211138 - 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) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211138 · Stryker Sustainability Solutions · Anesthesiology device
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Mar 2022
Decision
326d
Days
Class 2
Risk

K211138 is an FDA 510(k) clearance for the Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (.... 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 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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Submission Details

510(k) Number K211138 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
187d slower than avg
Panel avg: 139d · This submission: 326d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - NLF Oximeter, Reprocessed

All 26
Devices cleared under the same product code (NLF) and FDA review panel - the closest regulatory comparables to K211138.
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000)
K241758 · Stryker Sustainability Solutions · Oct 2024
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)
K222019 · Stryker Sustainability Solutions · Dec 2022