510(k) · Cleared
ClearedSkyline 55, Model Ver 1
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 Nov 20, 2009 as substantially equivalent to K081552 (Larsen & Toubro Limited, 2008) and 1 other predicate after a 127-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Nov 20, 2009
- Review
- 127 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011093 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK011093 Agilent Information Center Software for M3150,M3151,M3153 and M3154Agilent Technologies, Inc. · 2001 · Recalled
- 1 generation backK062194 Hypervisor VI Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- This deviceK092153 Skyline 55, Model Ver 1Larsen & Toubro Limited · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154 | Agilent Technologies, Inc. | 2001 | 4 |
| −1 | K062194 | Hypervisor VI Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| 0 (this device) | K092153 | Skyline 55, Model Ver 1 | Larsen & Toubro Limited | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K081552 | Skyline 55Summary page 1…-Cardiovascular Device Class Class II Legally marketed Comparison Device / · SKYLINE 55 Ver 0/ K081552 * Mindray HYPERVISOR VI /… | 2008 |
| * | K062194 | Hypervisor VI Central Monitoring SystemSummary page 1…Ver 0/ K081552 * Mindray HYPERVISOR VI / K062194 Ragd. Off: L&T House, Ballard Estate, P.O Box 278, Mumhai 400 001 · Phone: +91 (22)67525656 · Fax: +91 (22)67525858… | 2007 |
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 8 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
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. 2009, 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 Skyline55 Ver 1 is Central Nursing System Software that is loaded in a PC, which in turn is connected to a listed patient monitor via an Ethernet communication (wired or wireless). The system software will enable a user to simultaneously monitor 8/16 beds. The system software will make available to the user, patient information in the form of continuous monitoring along with extended features in which 72-hour trend data can be stored for each patient…
Read the full statement (182 words)
The Skyline55 Ver 1 is Central Nursing System Software that is loaded in a PC, which in turn is connected to a listed patient monitor via an Ethernet communication (wired or wireless). The system software will enable a user to simultaneously monitor 8/16 beds. The system software will make available to the user, patient information in the form of continuous monitoring along with extended features in which 72-hour trend data can be stored for each patient and displayed in the form of Waveform recall, Graphical and Tabular Trends. Alarm records for 72-hours too are recorded and stored for each patient connected to the system software.
Skyline 55 Ver1 is intended to conduct centralized monitoring for adult, pediatric and neonatal patients' vital sign information from multiple monitors in a hospital, the monitoring parameters include ECG, NIBP, SPO2, RESP, IBP, TEMP, C02 and Anesthesia agents.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The system software permits patient monitoring with adjustable visible and audible alarm signals. The system software is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092153: Skyline 55, Model Ver 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092153
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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