510(k) · Cleared
ClearedLife Support for Trauma and Transport
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Northrop Grumman Corp. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Jun 26, 1998 after a 553-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Jun 26, 1998
- Review
- 553 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK965117 Life Support for Trauma and TransportNorthrop Grumman Corp. · 1998
- Descendant · cites it directly · 0 of its ownK082256 Life Support for Trauma and Trnsport (Lstat) G6 LiteIntegrated Medical Systems, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K082256Life Support for Trauma and Trnsport (Lstat) G6 LiteIntegrated Medical Systems, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965117 | Life Support for Trauma and Transport | Northrop Grumman Corp. | 1998 | — |
| +1 | K082256 | Life Support for Trauma and Trnsport (Lstat) G6 Lite | Integrated Medical Systems, Inc. | 2008 | — |
Descendants 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 MKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K082256 | Life Support for Trauma and Trnsport (Lstat) G6 Lite | 2008 | 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?
- Of its descendants, K082256 (Integrated Medical Systems, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, 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 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
The Life Support for Trauma and Transport (LSTAT) is a portable system providing Intensive Care Unit (ICU) functionality for adult patients. Its use as a device is to provide in a single platform: physiological monitoring, upper airway or gastrointestinal drainage suction, automated external defibrillation, IV and drug administration pumping, ventilation and oxygen delivery for use in hospitals, aircraft, ambulances, field hospitals and extended care facilities. Defibrillation is only applied to unconscious pulseless and apneic patients weighing over 90 pounds. Operating power is furnished via external AC, external DC or internal rechargeable batteries
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965117: Life Support for Trauma and Transport.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965117
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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