510(k) · Cleared
ClearedRenu Medical Oximetry Sensor, Adult, Ped, Inf,Neo
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 Feb 6, 2009 after a 214-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Feb 6, 2009
- Review
- 214 days
- Class
- Class II
- Product code
- NLF
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK081927 Renu Medical Oximetry Sensor, Adult, Ped, Inf,NeoRenu Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK111773 Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant…Renu Medical, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- 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) | K081927 | Renu Medical Oximetry Sensor, Adult, Ped, Inf,Neo | Renu Medical, Inc. | 2009 | — |
| +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 |
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 |
|---|---|---|---|
| * | — | Masimo LNCS Adtx Oximetry sensor Named without a submission number | |
| * | — | Masimo LNCS Pdtx Oximetry sensor Named without a submission number | |
| * | — | Masimo LNCS Inf Oximetry sensor Named without a submission number | |
| * | — | Masimo LNCS Neo Oximetry sensor Named without a submission number |
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 |
|---|---|---|---|
| K111773 | Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate | 2011 | 0 |
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, K111773 (Renu Medical, Inc., 2011) 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. 2009, 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 ReNu Medical Reprocessed Oximetry Sensors are intended as single patient use 02 transducer/accessory sensors for use in conjunction with the Masimo TMMOximeter system.
The LNCS Adult is used for patients >30 kg.
The LNCS Pediatric is used for patients 10-50 kg.
The LNCS Infant is used for patients 3-20 kg.
The LNCS Neo is used for neonates <3 kg or adults >40 kg.
All sensors are used for non-invasive monitoring of pulse oxygen hemoglobin saturation (Sp02) and pulse rate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081927: Renu Medical Oximetry Sensor, Adult, Ped, Inf,Neo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081927
Report an extraction error
Are you the manufacturer?
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