510(k) · Cleared
ClearedRenu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renu Medical, Inc. · NLF Oximeter, Reprocessed
Cleared on Nov 29, 2007 after a 114-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Nov 29, 2007
- Review
- 114 days
- Class
- Class II
- Product code
- NLF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK072194 Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25Renu Medical, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK113727 Shenzhen Med-Link Pulse Oximeter ProbeShenzhen Med-Link Electronics Tech Co., Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK183277 SpO2 SensorShenzhen Upnmed Equipment Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK111773 Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant…Renu Medical, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- K113727Shenzhen Med-Link Pulse Oximeter ProbeShenzhen Med-Link Electronics Tech Co., Ltd. · 2013 · cites it directly1descendant
- K183277SpO2 SensorShenzhen Upnmed Equipment Co., Ltd. · 2019 · 2 generations on0descendants
- K111773Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and NeonateRenu Medical, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072194 | Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25 | Renu Medical, Inc. | 2007 | — |
| +1 | K113727 | Shenzhen Med-Link Pulse Oximeter Probe | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2013 | — |
| +2 | K183277 | SpO2 Sensor | Shenzhen Upnmed Equipment Co., Ltd. | 2019 | — |
| +1 | K111773 | Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate | Renu Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | — | Nellcor D-25 Oximetry sensor Named without a submission number | |
| * | — | Nellcor N-25 Oximetry sensor Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K113727 (Shenzhen Med-Link Electronics Tech Co., Ltd., 2013) has gone furthest, with 1 descendant 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. 2007, 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?
D-25 continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg.
N-25: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients foot if < 3 kg, or finger if > 40 kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072194: Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072194
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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