510(k) · Cleared
ClearedLife Support for Trauma and Trnsport (Lstat) G6 Lite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrated Medical Systems, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Sep 26, 2008 as substantially equivalent to K965117 (Northrop Grumman Corp., 1998) after a 49-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Sep 26, 2008
- Review
- 49 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K965117 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK965117 Life Support for Trauma and TransportNorthrop Grumman Corp. · 1998
- This deviceK082256 Life Support for Trauma and Trnsport (Lstat) G6 LiteIntegrated Medical Systems, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965117 | Life Support for Trauma and Transport | Northrop Grumman Corp. | 1998 | — |
| 0 (this device) | K082256 | Life Support for Trauma and Trnsport (Lstat) G6 Lite | Integrated Medical Systems, Inc. | 2008 | — |
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 |
|---|---|---|---|
| * | K965117 | Life Support for Trauma and TransportSummary page 1…Product Code FRN) Substantial Equivalence: The Integrated Medical Systems LSTAT G6 Lite is substantially equivalent to the Integrated Medical Systems LSTAT 9602 (K965117) since the basic features, design and intended uses are the same or similar. The differences in design, dimensions, and features… | 1998 |
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?
- Its one ancestor has no recall.
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. 2008, 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 Life Support for Trauma and Transport (LSTAT) G6 Lite System is a portable unit intended to supply intensive care unit (ICU) functionality for adult and pediatric patients. The LSTAT G6 Lite combines the following medical device capabilities into a single platform: Physiological monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, pulse rate, blood oxygen saturation, and heart rate), low…
Read the full statement (134 words)
The Life Support for Trauma and Transport (LSTAT) G6 Lite System is a portable unit intended to supply intensive care unit (ICU) functionality for adult and pediatric patients. The LSTAT G6 Lite combines the following medical device capabilities into a single platform: Physiological monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, pulse rate, blood oxygen saturation, and heart rate), low rate and high rate infusion pumps, a fluid warmer, a ventilator with carbon dioxide monitoring capabilities, and the ability to deliver oxygen to a patient. The functions of the LSTAT G6 Lite are controlled from a central user interface. The G6 Lite may be operated using either battery power or an external power source. The G6 Lite is intended to be used in hospitals, aircraft, ambulances, field hospitals, and extended care facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082256: Life Support for Trauma and Trnsport (Lstat) G6 Lite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082256
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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