510(k) · Cleared
ClearedStar 50 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 Jun 29, 2005 as substantially equivalent to K952474 (Marquette Electronics, Inc., 1995) and 2 other predicates after a 12-day review. Its family tree reaches back 2 generations to 1995. 1 of the 263 devices in its family, counting itself, has a Class I recall. 259 later devices descend from it.
- Decided
- Jun 29, 2005
- Review
- 12 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K952474 (1995). 3 ancestors in all. 259 later devices descend from it, 4 citing it directly. 1 of the 263 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK952474 Eagle 3000 Patient MonitorMarquette Electronics, Inc. · 1995
- 1 generation backK032867 Star (Lunar Series) Monitoring SystemLarsen & Toubro Limited · 2003
- This deviceK051608 Star 50 Monitoring SystemLarsen & Toubro Limited · 2005
- Descendant · cites it directly · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- Descendant · 3 generations on · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 155 of its ownK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- Descendant · 5 generations on · 115 of its ownK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
Showing 5 of 259 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K123690 CAPNOSTREAM20P with Hifi C02 Monitoring7 generations on · 2014
Most influential descendants
Showing 5 of 259 · See all- K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · cites it directly250descendants
- K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 2 generations on197descendants
- K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · 3 generations on170descendants
- K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation · 2009 · 4 generations on155descendants
- K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010 · 5 generations on115descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952474 | Eagle 3000 Patient Monitor | Marquette Electronics, Inc. | 1995 | — |
| −1 | K032867 | Star (Lunar Series) Monitoring System | Larsen & Toubro Limited | 2003 | — |
| 0 (this device) | K051608 | Star 50 Monitoring System | Larsen & Toubro Limited | 2005 | — |
| +1 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| +2 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| +3 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| +4 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| +5 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
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 |
|---|---|---|
| 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? (3)
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…System (Marquette Electronic) / K952474 Vital signs monitor Model 8100… | 1995 |
| * | K001020 | 8100 Vital Signs MonitorSummary page 4…temn. Predicate device Eagle 3000 patient Monitoring System (Marquetle Electronic). KN K952474 Vital signs monitor Model 8100 (CSI), KA' K001020 Patient Monitoring System - STAR. (Larsen & Toubro Limited), K# K032867 The parameters available with thes… | 2000 |
| * | K032867 | Star (Lunar Series) Monitoring SystemSummary page 2…STAR, (Larsen & Toubro Limited), K# K032867 Seged. Off: L &T House, Ballard Eslate. P 0 Box 278. MunMbai 400 001* Prone 261 81:BI82 , Fax 91 -2 2620223… | 2003 |
What descends from it? (259)
See all 2594 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 7 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K060065 (Oridion Capnography, Inc., 2006) has gone furthest, with 250 descendants of its own.
- 4 other devices also cite its predicate K952474.
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 50 unit is a multi-parameter 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 / II/III / V / AVL / AVF AVR), Plethysmograph, Respiration, lIvasive Blood Pressure (IBP1 & IBP2) and Capnography (CO2). . It can also display…
Read the full statement (156 words)
The STAR 50 unit is a multi-parameter 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 / II/III / V / AVL / AVF AVR), Plethysmograph, Respiration, lIvasive Blood Pressure (IBP1 & IBP2) and Capnography (CO2). . It can also display the digital values of HR/PR~, SpO2, R, Non-Invasive & Invasive Blood Pressure (systolic, diastolic and mean) and Temperature, EtCO2 and FiCO 2 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 arrhythmia provided is only a rate related arrhythmia without alarms. The monitor is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051608 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051608: Star 50 Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051608
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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