# NLF: Oximeter, Reprocessed

- Device class: 2; regulation: 21 CFR 870.2700; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 149 days (middle half 137–238)
- Recalls: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2005: 2
- 2007: 2
- 2008: 2
- 2009: 3
- 2010: 1
- 2011: 3
- 2019: 1
- 2020: 1
- 2022: 2
- 2024: 1

## Most-cited predicates
- K041867: Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-N (2004), cited by 2
- K083719: LNCS Oximetry Sensors (2009), cited by 2
- K072194: Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25 (2007), cited by 2
- K012715: Hygia Health Services Reprocessed Nellcot D-25 Oxisensor II (2003), cited by 1
- K033973: Oxisensor II Recycled Sensor and Oximax Recycled Sensor (2004), cited by 1
- K042316: Vanguard Reprocessed Pulse Oximeter Sensors (2005), cited by 1
- K063661: Renu Reprocessed Nellcor Oxysensor, Models D-20 and I-20 (2007), cited by 1
- K081238: Reprocessed Masimo Pulse Oximeter Sensors (2008), cited by 1
- K012677: Reprocessed Pulse Oximeter Sensors (2003), cited by 1
- 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), cited by 1

Source page: https://510kreport.com/product-code/NLF
Data by year (CSV): https://510kreport.com/product-code/NLF.csv