510(k) · Cleared
ClearedPlanet 55
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 Sep 21, 2007 as substantially equivalent to K043370 (Larsen & Toubro Limited, 2005) and 1 other predicate after a 115-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Sep 21, 2007
- Review
- 115 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K952474 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK071472 Planet 55Larsen & Toubro Limited · 2007
- Descendant · cites it directly · 0 of its ownK090443 Planet 55, Model 100Larsen & Toubro Limited · 2009
Most influential descendants
Showing 1 of 1 · See all- K090443Planet 55, Model 100Larsen & Toubro Limited · 2009 · cites it directly0descendants
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) | K071472 | Planet 55 | Larsen & Toubro Limited | 2007 | — |
| +1 | K090443 | Planet 55, Model 100 | Larsen & Toubro Limited | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K043370 | Planet 50 Monitoring SystemSummary page 2…System (L&T Medical Equipments & systems) / K043370 * STAR 50 Patient Monitoring… | 2005 |
| * | K051608 | Star 50 Monitoring SystemSummary page 2…System (L&T Medical Equipments & systems) / K051608 Regd. Off: L&T House, Ballard Estate, RO. Box 278, Mumbai 400 001 * Phone: +91(22)2261 8181 / 82 · Fax: +91(22)2262 0223… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090443 | Planet 55, Model 100 | 2009 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K090443 (Larsen & Toubro Limited, 2009) has gone furthest, with 0 descendants of its own.
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. 2007, 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?
The PLANET 55 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 (3 lead /5 lead), SpO2, Respiration, Temperature and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure…
Read the full statement (119 words)
The PLANET 55 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 (3 lead /5 lead), SpO2, Respiration, Temperature and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), 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 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/K071472 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071472: Planet 55.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071472
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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