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510(k) K042891

DATEX-OHMEDA OXY-AFR SENSOR by Datex-Ohmeda — Product Code NLF

K042891 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda for the device "DATEX-OHMEDA OXY-AFR SENSOR". The FDA issued a decision of Substantially Equivalent on June 29, 2005. The device falls under product code NLF (Oximeter, Reprocessed), a Class II device regulated under 21 CFR 870.2700. Datex-Ohmeda has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2005
Date Received
October 19, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Reprocessed
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

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).

Other clearances by Datex-Ohmeda

  • K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (October 22, 2025)
  • K213867 — Carestation 750/750c (March 28, 2023)
  • K210384 — CARESCAPE R860 (November 4, 2021)
  • K172702 — Tec 820, Tec 850 (January 4, 2018)
  • K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)
  • K170872 — Aisys CS2 (August 15, 2017)
  • K151570 — Carestation 620/650/650C (January 21, 2016)
  • K142679 — CARESCAPE R860 (June 12, 2015)
  • K143530 — Aespire View (April 24, 2015)
  • K140575 — ENGSTROM CARESTATION, ENGSTROM PRO (February 3, 2015)

Other clearances for product code NLF

  • K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pul (October 22, 2024)
  • K222019 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Puls (December 4, 2022)
  • K211138 — Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-2 (March 8, 2022)
  • K201699 — Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (July 22, 2020)
  • K191018 — Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive (July 3, 2019)
  • K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE (November 16, 2011)
  • K110723 — M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS (July 28, 2011)
  • K102560 — REPROCESSED PULSE OXIMETER SENSORS (February 18, 2011)
  • K101280 — MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE (October 7, 2010)
  • K092368 — REPROCESSED PULSE OXIMETER SENSORS (November 3, 2009)

FDA data resources