510(k) · Cleared
ClearedStellar 404 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 Oct 6, 2004 as substantially equivalent to K032871 (Larsen & Toubro Limited, 2003) after a 15-day review. Its family tree reaches back 2 generations to 1995. 7 later devices descend from it.
- Decided
- Oct 6, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952474 (1995). 3 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK952474 Eagle 3000 Patient MonitorMarquette Electronics, Inc. · 1995
- 1 generation backK032871 Planet Monitoring SystemLarsen & Toubro Limited · 2003
- This deviceK042560 Stellar 404 Monitoring SystemLarsen & Toubro Limited · 2004
- Descendant · cites it directly · 6 of its ownK060058 Stellar 404TLarsen & Toubro Limited · 2006
- Descendant · 2 generations on · 2 of its ownK103763 Stellar 300Larsen & Toubro Limited · 2011
- Descendant · 2 generations on · 2 of its ownK093017 Stellar 300Larsen & Toubro Limited · 2010
- Descendant · 3 generations on · 1 of its ownK103686 STAR 50 NLarsen & Toubro Limited · 2011
- Descendant · 3 generations on · 0 of its ownK152831 Spot SkanSkanray Technologies Private Limited · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K060058Stellar 404TLarsen & Toubro Limited · 2006 · cites it directly6descendants
- K103763Stellar 300Larsen & Toubro Limited · 2011 · 2 generations on2descendants
- K093017Stellar 300Larsen & Toubro Limited · 2010 · 2 generations on2descendants
- K103686STAR 50 NLarsen & Toubro Limited · 2011 · 3 generations on1descendant
- K152831Spot SkanSkanray Technologies Private Limited · 2016 · 3 generations on0descendants
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 | K032871 | Planet Monitoring System | Larsen & Toubro Limited | 2003 | — |
| 0 (this device) | K042560 | Stellar 404 Monitoring System | Larsen & Toubro Limited | 2004 | — |
| +1 | K060058 | Stellar 404T | Larsen & Toubro Limited | 2006 | — |
| +2 | K103763 | Stellar 300 | Larsen & Toubro Limited | 2011 | — |
| +2 | K093017 | Stellar 300 | Larsen & Toubro Limited | 2010 | — |
| +3 | K103686 | STAR 50 N | Larsen & Toubro Limited | 2011 | — |
| +3 | K152831 | Spot Skan | Skanray Technologies Private Limited | 2016 | — |
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 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K032871 | Planet Monitoring SystemSummary page 2…System (L&T Medidal Equipments & systems) / K032871 Regd. Off.: L&T House, Ballard Estate. P.0. Box 278, Mumbai 400 001 · Tel.: 261 8181/82 - f:-, 91-22-262 0223 === Pag… | 2003 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060058 | Stellar 404T | 2006 | 6 |
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 9 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, K060058 (Larsen & Toubro Limited, 2006) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K032871.
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 STELLAR 404 two parameter Patient Monitoring System is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during hospital transport along with the appropriate accessories mentioned/ supplied with the unit. Vital signs parameter includes Plethysmograph. It can also display the digital values of PR, SPO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) readings. The user, responsible to…
Read the full statement (111 words)
The STELLAR 404 two parameter Patient Monitoring System is intended to
monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or
during hospital transport along with the appropriate accessories mentioned/
supplied with the unit. Vital signs parameter includes Plethysmograph. It can
also display the digital values of PR, SPO2, Non-Invasive Blood Pressure
(Systolic, Diastolic and Mean) 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/K042560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042560: Stellar 404 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/K042560
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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