Oximeter, Reprocessed
Cardiovascular · 21 CFR 870.2700
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).
Recent MDR events
89 adverse event reports on file
- Nellcor Pulse Oximeter ProbeJul 29, 2026MalfunctionMedline Renewal3032391-2026-00062
- Nellcor Pulse Oximeter ProbeJul 29, 2026MalfunctionMedline Renewal3032391-2026-00063
- NELLCOR PULSE OXIMETER PROBEJun 22, 2026MalfunctionMedline Renewal3032391-2026-00042
- NELLCOR PULSE OXIMETER PROBEJun 19, 2026MalfunctionMedline Renewal3032391-2026-00037
- MASIMO LNCS® ADTX-3 ADULT SPO2 SENSORJun 19, 2026MalfunctionMedline Renewal3032391-2026-00038
- NELLCOR PULSE OXIMETER PROBEJun 18, 2026MalfunctionMedline Renewal3032391-2026-00035
- NELLCOR PULSE OXIMETERJun 11, 2026MalfunctionMedline Renewal3032391-2026-00032
- NELLCOR PULSE OXIMETERJun 11, 2026MalfunctionMedline Renewal3032391-2026-00031
- NELLCOR PULSE OXIMETERJun 7, 2026MalfunctionMedline Renewal3032391-2026-00027
- NELLCOR PULSE OXIMETERJun 7, 2026MalfunctionMedline Renewal3032391-2026-00026
Event type breakdown
Recalls
3 recall events for this product code
- Ascent Healthcare Solutions, Inc.TerminatedSep 19, 2008
Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device -- Pulse Oximeter.
Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
Z-1663-2008 · View FDA record ↗ - Ascent Healthcare Solutions, Inc.TerminatedSep 19, 2008
Adult 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter.
Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
Z-1664-2008 · View FDA record ↗ - Ascent Healthcare Solutions, Inc.TerminatedSep 19, 2008
Infant 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter.
Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
Z-1683-2008 · View FDA record ↗
Registered firms
56 firms currently registered for this product code
Stryker Tijuana Operations
Tijuana Baja California, MX
Stryker Sustainability Solutions
Tempe, AZ, US
Sterigenics U.s., Llc
Atlanta, GA, US
Isomedix Operations, Inc.
Temecula, CA, US
Medline Renewal
Redmond, OR, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Isomedix Operations Inc.
SAN DIEGO, CA, US
Isomedix Operations Inc.
GRAND PRAIRIE, TX, US
Masimo Corporation
Irvine, CA, US
Covidien
Lafayette, CO, US
Sterigenics U.s., Llc
Ontario, CA, US
Stryker Sustainability Solutions - Chandler
Chandler, AZ, US
Renu Medical, Inc.
EVERETT, WA, US
Nypro Inc (maple Grove)
Maple Grove, MN, US
510(k) clearances
27 clearances for this product code
- Stryker Sustainability SolutionsOct 22, 2024
K241758 · 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)
- Stryker Sustainability SolutionsDec 4, 2022
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)
- Stryker Sustainability SolutionsMar 8, 2022
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)
- Surgical Instrument and Savings Inc (Dba Medline Renewal)Jul 22, 2020
K201699 · Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
- Surgical Instrument Service and Savings, Inc.Jul 3, 2019
K191018 · Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
- Renu Medical, Inc.Nov 16, 2011
K111773 · RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
- Masimo CorporationJul 28, 2011
K110723 · M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
- Sterilmed, Inc.Feb 18, 2011
K102560 · REPROCESSED PULSE OXIMETER SENSORS