510(k) · Cleared
ClearedGalaxy
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 Jul 12, 2006 as substantially equivalent to K051608 (Larsen & Toubro Limited, 2005) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jul 12, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K952474 (1995). 7 ancestors in all, the oldest K913995 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK952474 Eagle 3000 Patient MonitorMarquette Electronics, Inc. · 1995
- 2 generations backK032867 Star (Lunar Series) Monitoring SystemLarsen & Toubro Limited · 2003
- 1 generation backK051608 Star 50 Monitoring SystemLarsen & Toubro Limited · 2005
- This deviceK061816 GalaxyLarsen & Toubro Limited · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952474 | Eagle 3000 Patient Monitor | Marquette Electronics, Inc. | 1995 | — |
| −2 | K032867 | Star (Lunar Series) Monitoring System | Larsen & Toubro Limited | 2003 | — |
| −1 | K051608 | Star 50 Monitoring System | Larsen & Toubro Limited | 2005 | — |
| 0 (this device) | K061816 | Galaxy | Larsen & Toubro Limited | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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? (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 |
|---|---|---|---|
| * | K051608 | Star 50 Monitoring SystemSummary page 2…50 (Larsen & Toubro Limited), K# K051608 Vamos Anesthetic Gas Monitor… | 2005 |
| * | K012139 | Vamos Anesthetic Gas MonitorSummary page 2…Vamos Anesthetic Gas Monitor (Draeger Medical), K# K012139 Regd. Off: L &T House Ballard Estate. PO Box 278, Mumbaj 400 001 * Phone. t 91(22)2261 8181 82 * Fax: -91(22)2262 0223… | 2002 |
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 11 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 7 ancestors has a recall.
- 3 other devices also cite its predicate K051608.
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 Galaxy 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 / 1I / III / V / AVL / AVE / AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBPI & IBP2), Capnography (CO 2) & Anesthesia agents. It can also…
Read the full statement (151 words)
The Galaxy 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 / 1I / III / V / AVL / AVE / AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBPI & IBP2), Capnography (CO 2) & Anesthesia agents. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean), Tempcrature, EtCO 2, FiCO 2 , EtAA and FiAA 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 as stated in the FDA summary.
https://510kreport.com/device/K061816 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061816: Galaxy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061816
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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