510(k) · Cleared
ClearedStar (Lunar Series) Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Larsen & Toubro Limited · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Nov 10, 2003 as substantially equivalent to K952474 (Marquette Electronics, Inc., 1995) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1995. 1 of the 263 devices in its family, counting itself, has a Class I recall. 260 later devices descend from it.
- Decided
- Nov 10, 2003
- Review
- 56 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K952474 (1995). 2 ancestors in all. 260 later devices descend from it, 1 citing it directly. 1 of the 263 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK952474 Eagle 3000 Patient MonitorMarquette Electronics, Inc. · 1995
- This deviceK032867 Star (Lunar Series) Monitoring SystemLarsen & Toubro Limited · 2003
- Descendant · cites it directly · 259 of its ownK051608 Star 50 Monitoring SystemLarsen & Toubro Limited · 2005
- Descendant · 2 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- Descendant · 4 generations on · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- Descendant · 5 generations on · 155 of its ownK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
Showing 5 of 260 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K123690 CAPNOSTREAM20P with Hifi C02 Monitoring8 generations on · 2014
Most influential descendants
Showing 5 of 260 · See all- K051608Star 50 Monitoring SystemLarsen & Toubro Limited · 2005 · cites it directly259descendants
- K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 2 generations on250descendants
- K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 3 generations on197descendants
- K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · 4 generations on170descendants
- K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation · 2009 · 5 generations on155descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952474 | Eagle 3000 Patient Monitor | Marquette Electronics, Inc. | 1995 | — |
| 0 (this device) | K032867 | Star (Lunar Series) Monitoring System | Larsen & Toubro Limited | 2003 | — |
| +1 | K051608 | Star 50 Monitoring System | Larsen & Toubro Limited | 2005 | — |
| +2 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| +3 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| +4 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| +5 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 9 | 0 |
| 2010 | 8 | 0 |
| 2011 | 7 | 0 |
| 2012 | 13 | 0 |
| 2013 | 15 | 0 |
| 2014 | 17 | 1 |
| 2015 | 11 | 0 |
| 2016 | 10 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 16 | 0 |
| 2020 | 15 | 0 |
| 2021 | 11 | 0 |
| 2022 | 24 | 0 |
| 2023 | 16 | 0 |
| 2024 | 20 | 0 |
| 2025 | 18 | 0 |
| 2026 | 15 | 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.
1 device in this family has 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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 |
|---|---|---|---|
| * | K952474 | Eagle 3000 Patient MonitorSummary page 2…Ii# System Warquette Electronic) / K952474 Vital signs monitor Model 8 100… | 1995 |
| * | K001020 | 8100 Vital Signs MonitorSummary page 4…System. Predicatc device : Eaglc 3000 patient Monitoring System (Marqucttc Elcctronic), K+f K952474 Vital signs monitor Model 8100 (CSI), K# K001020 Thc parameters avaitable with these predicate deviccs arc available u i t h the Larscrl & Toubro Limited make STAR… | 2000 |
What descends from it? (260)
See all 2601 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051608 | Star 50 Monitoring System | 2005 | 259 |
Has anything in its family been recalled? (1 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.
- K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The STAR (LUNAR SERIES) multiparameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (Lead I / I1 / III / V / AVL / AVF / AVR), Plethysmograph, Respiration and Invasive Blood pressure ( B P I & IBP2). It can also display the digital…
Read the full statement (144 words)
The STAR (LUNAR SERIES) multiparameter Patient Monitoring system is intended to
monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during
intra-hospital transport along with the appropriate accessories mentioned / supplied with
the unit. Vital signs parameters include ECG (Lead I / I1 / III / V / AVL / AVF / AVR),
Plethysmograph, Respiration and Invasive Blood pressure ( B P I & IBP2). It can also
display the digital values of HR/PR, SpOz, RR, Non-Invasive & Invasive Blood Pressure
(Systolic, Diastolic and Mean) and Temperature readings.
The user, responsible to interpret the monitored data made available, will be a
professional health care provider. The device, which can also be used as a portable
device, permits patient monitoring with adjustable alarm limits as well as visible and
audible alarm signals. The monitor is not intended for home use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K032867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032867: Star (Lunar Series) Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032867
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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