510(k) · Cleared
ClearedReprocessed 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)
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 Mar 8, 2022 as substantially equivalent to K042316 (Vanguard Medical Concepts, Inc., 2005) and 3 other predicates after a 326-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Mar 8, 2022
- Review
- 326 days
- Class
- Class II
- Product code
- NLF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K962603 (1997). 11 ancestors in all, the oldest K904039 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 1 generation backK042316 Vanguard Reprocessed Pulse Oximeter SensorsVanguard Medical Concepts, Inc. · 2005
- This deviceK211138 Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter…Stryker Sustainability Solutions · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −1 | K042316 | Vanguard Reprocessed Pulse Oximeter Sensors | Vanguard Medical Concepts, Inc. | 2005 | — |
| 0 (this device) | K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor… | Stryker Sustainability Solutions | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 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.
Planning a device in NLF? 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? (4)
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 |
|---|---|---|---|
| * | K042316 | Vanguard Reprocessed Pulse Oximeter SensorsSummary page 4…duct Code NLF Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K042316 Vanguard Reprocessed Pulse Oximeter Sensors NLF K012344 Vanguard Reprocessed Pulse Oxi… | 2005 |
| * | K012344 | Vanguard Reprocessed Pulse Oximeter SensorsSummary page 4…edicate Trade Name (Primary Predicate is listed first) Product Code K042316 Vanguard Reprocessed Pulse Oximeter Sensors NLF K012344 Vanguard Reprocessed Pulse Oximeter Sensors NLF K012891 OxiMax Pulse Oximetry System w… | 2002 |
| * | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Summary page 4…Vanguard Reprocessed Pulse Oximeter Sensors NLF K012344 Vanguard Reprocessed Pulse Oximeter Sensors NLF K012891 OxiMax Pulse Oximetry System with N-595 Pulse Oximeter and DQA OxiMax Sensors and Cables K993… | 2002 |
| * | K993637 | N-395 Pulse Oximeter, with Extended Device ClaimsSummary page 4…Sensors NLF K012891 OxiMax Pulse Oximetry System with N-595 Pulse Oximeter and DQA OxiMax Sensors and Cables K993637 N-395 Pulse Oximeter, with extended device claims DQA Stryker Sustainability Solutions… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 11 ancestors have a recall of any class.
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 sensor is indicated for single patient use for continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211138 · printed Nov 6, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211138
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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