510(k) · Cleared
ClearedStar 60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skanray Technologies Private Limited · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Feb 14, 2016 as substantially equivalent to K101680 (Welch Allyn, Inc., 2010) and 3 other predicates after a 255-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Feb 14, 2016
- Review
- 255 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K941811 (1994). 61 ancestors in all, the oldest K893221 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations between
- 3 generations backK080495 Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems · 2008 · Recalled
- 2 generations backK082280 Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor…Philips Medical Systems North America Co. · 2008
- 1 generation backK120132 Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorPhilips Medical Systems · 2012
- This deviceK151512 Star 60Skanray Technologies Private Limited · 2016
Show all 9 generations
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 8 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 7 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 6 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 5 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 4 generations backK052707 M3046B Compact Portable Patient MonitorsPhilips Medical Systems · 2005 · Recalled
- 3 generations backK080495 Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems · 2008 · Recalled
- 2 generations backK082280 Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor…Philips Medical Systems North America Co. · 2008
- 1 generation backK120132 Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorPhilips Medical Systems · 2012
- This deviceK151512 Star 60Skanray Technologies Private Limited · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −8 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −7 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −6 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −5 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −4 | K052707 | M3046B Compact Portable Patient Monitors | Philips Medical Systems | 2005 | 1 |
| −3 | K080495 | Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3 | Philips Medical Systems | 2008 | 1 |
| −2 | K082280 | Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns… | Philips Medical Systems North America Co. | 2008 | — |
| −1 | K120132 | Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs Monitor | Philips Medical Systems | 2012 | — |
| 0 (this device) | K151512 | Star 60 | Skanray Technologies Private Limited | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 8 | 0 |
| 1999 | 2 | 0 |
| 2000 | 10 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 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 MWI? 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? (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 |
|---|---|---|---|
| * | K101680 | Welch Allyn Spot Vital Signs Lxi Model 45000 SeriesSummary page 4…Predicate Device Company Product 510(k) # Welch Allyn Spot Vital Signs LXi K101680 Philips Medical Systems SureSigns VS4 K120132 Suntech Medicals Cycle BP Monitor & Pu… | 2010 |
| * | K120132 | Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorSummary page 4…510(k) # Welch Allyn Spot Vital Signs LXi K101680 Philips Medical Systems SureSigns VS4 K120132 Suntech Medicals Cycle BP Monitor & Pulse Oximeter, Model 1060 K0608… | 2012 |
| * | K060820 | Cycle BP Monitor and Pulse Oximeter, Model 1060Summary page 4…igns VS4 K120132 Suntech Medicals Cycle BP Monitor & Pulse Oximeter, Model 1060 K060820 L&T Medical & Systems Stellar 300 K103763 510K Summary – Star 60… | 2006 |
| * | K103763 | Stellar 300Summary page 4…le BP Monitor & Pulse Oximeter, Model 1060 K060820 L&T Medical & Systems Stellar 300 K103763 510K Summary – Star 60 Page 1 of 4 Device Descript… | 2011 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 7 of the 61 ancestors have a recall of any class.
- 4 other devices also cite its predicate K101680.
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. 2016, this device’s year, is highlighted.
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?
Star 60 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 (3L/5L), SpO2, Respiration, Temperature, NIBP, IBP and Capnography (CO2). It can also display the numerical values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure…
Read the full statement (123 words)
Star 60 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 (3L/5L), SpO2, Respiration, Temperature, NIBP, IBP and Capnography (CO2). It can also display the numerical values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2 readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The 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 as stated in the FDA summary.
https://510kreport.com/device/K151512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151512: Star 60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151512
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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