Reprocessed RD SET Adt Pulse Oximeter Sensor (4000) +3 more— 510(k) K241758

Clearance details

Device name as filed

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)

Applicant

Stryker Sustainability Solutions

Product code

Code NLF

Device class

Class 2

Regulation

21 CFR 870.2700

Advisory panel

Cardiovascular

Date received

2024-06-20

Decision date

2024-10-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tempe, AZ, US

• 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)2022-12-04
• 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)2022-03-08
• K201699 — Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor2020-07-22
• K191018 — Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors2019-07-03
• K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE2011-11-16

• K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating2026-06-18
• K250898 — Reprocessed HARMONIC 700 Shears (3 models)2025-08-14
• K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120) +1 more2024-07-03
• K233471 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120) +1 more2024-02-20
• K231621 — Reprocessed ViewFlex Xtra ICE Catheter (D087031)2023-07-25