Cleared Traditional

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)

K241758 · Stryker Sustainability Solutions · Anesthesiology
Oct 2024
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K241758 is an FDA 510(k) clearance for the 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), a Oximeter, Reprocessed (Class II — Special Controls, product code NLF), submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on October 22, 2024, 124 days after receiving the submission on June 20, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K241758 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2024
Decision Date October 22, 2024
Days to Decision 124 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code NLF — Oximeter, Reprocessed
Device Class Class II — 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).

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