510(k) · Cleared
ClearedReprocessed 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)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Sustainability Solutions · NLF Oximeter, Reprocessed
Cleared on Dec 4, 2022 as substantially equivalent to K211140 (Stryker Sustainability Solutions, 2022) and 1 other predicate after a 149-day review. Its family tree reaches back 21 generations to 1997. 2 of the 156 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Dec 4, 2022
- Review
- 149 days
- Class
- Class II
- Product code
- NLF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K962603 (1997). 154 ancestors in all, the oldest K853990 (1985). 1 later device descends from it, 1 citing it directly. 2 of the 156 devices in this family, counting this one, have a Class I recall.
- Root · 21 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 17 generations between
- 3 generations backK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- 2 generations backK170168 Masimo Rad-97 and AccessoriesMasimo Corporation · 2017
- 1 generation backK180046 Masimo Rad-97 and AccessoriesMasimo Corporation · 2018 · Recalled
- This deviceK222019 Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD…Stryker Sustainability Solutions · 2022
- Descendant · cites it directly · 0 of its ownK241758 Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD…Stryker Sustainability Solutions · 2024
Show all 21 generations
- Root · 21 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 20 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 19 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 18 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 17 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 16 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 15 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 14 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 13 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 12 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 11 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 10 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 9 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 8 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 7 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 6 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 5 generations backK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- 4 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- 3 generations backK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- 2 generations backK170168 Masimo Rad-97 and AccessoriesMasimo Corporation · 2017
- 1 generation backK180046 Masimo Rad-97 and AccessoriesMasimo Corporation · 2018 · Recalled
- This deviceK222019 Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD…Stryker Sustainability Solutions · 2022
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −20 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −19 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −18 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −17 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −16 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −15 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −14 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −13 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −12 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −11 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −10 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −9 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −8 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −7 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −6 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| −5 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| −4 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| −3 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
| −2 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | — |
| −1 | K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018 | 1 |
| 0 (this device) | K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt… | Stryker Sustainability Solutions | 2022 | — |
| +1 | K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt… | Stryker Sustainability Solutions | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 1 |
| 1998 | 7 | 0 |
| 1999 | 15 | 0 |
| 2000 | 17 | 0 |
| 2001 | 5 | 0 |
| 2002 | 11 | 1 |
| 2003 | 10 | 0 |
| 2004 | 9 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NLF device
- #1 K241758 Reprocessed RD SET Adt Pulse Oximeter Sensor…score 14.5 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Summary page 4…lation Number: 870.2700 Product Code: NLF Legally Marketed Predicate Devices: Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211140 Reprocessed Masimo Pulse Oximeter (1859 Adult O2 NLF Transducer), Reprocessed Ma… | 2022 |
| * | K180046 | Masimo Rad-97 and AccessoriesSummary page 5…rocessed Masimo Pulse Oximeter (2328 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2329 Adult O2 Transducer) K180046 Masimo Rad-97 and Accessories DQA Device Description Summary: In a clinical setting, a… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse… | 2024 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 25 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 24 of the 154 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K241758 (Stryker Sustainability Solutions, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NLF devicesNLF Oximeter, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NLF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NLF
146in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLF
3in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLF
3in 2025
MAUDE reports naming product code NLF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 3 | 7 |
| 2009 | 3 | 214 | 0 | 3 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 3 | 146 | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 11 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Reprocessed RD SET pulse oximeter sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, and infant patients during non-motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222019 · printed Nov 6, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222019
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026