510(k) · Cleared
ClearedModification to Empower CT/Cta Injector System, Models 9800/9900 Product Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E-Z-Em, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 13, 2007 as substantially equivalent to K031571 (E-Z-Em, Inc., 2003) and 2 other predicates after a 27-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Jun 13, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K011160 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK011160 E-Z EM Percupump 2001 CT InjectorE-Z-Em, Inc. · 2001 · Recalled
- 2 generations backK031571 Empowercta Injector System, Models 9930 & 9910 & 9825E-Z-Em, Inc. · 2003 · Recalled
- 1 generation backK063029 Empower CT/Cta Injector System, Model 9800/9900E-Z-Em, Inc. · 2006
- This deviceK071378 Modification to Empower CT/Cta Injector System, Models 9800/9900…E-Z-Em, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK262115 VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011160 | E-Z EM Percupump 2001 CT Injector | E-Z-Em, Inc. | 2001 | 3 |
| −2 | K031571 | Empowercta Injector System, Models 9930 & 9910 & 9825 | E-Z-Em, Inc. | 2003 | 3 |
| −1 | K063029 | Empower CT/Cta Injector System, Model 9800/9900 | E-Z-Em, Inc. | 2006 | — |
| 0 (this device) | K071378 | Modification to Empower CT/Cta Injector System, Models 9800/9900 Product Series | E-Z-Em, Inc. | 2007 | — |
| +1 | K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | ACIST Medical Systems, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K031571 | Empowercta Injector System, Models 9930 & 9910 & 9825Summary page 1…CFR 870.2770 (Product Code DSB) 21 CFR 870.1650 (Product Code IZQ) Currently Marketed Devices: EmpowerCTA Injector System (K031571) (K063029) EmpowerCT Injector System (K011160) (K063029) New Indications for Use: The EmpowerCTA Inj… | 2003 |
| * | K063029 | Empower CT/Cta Injector System, Model 9800/9900Summary page 1…770 (Product Code DSB) 21 CFR 870.1650 (Product Code IZQ) Currently Marketed Devices: EmpowerCTA Injector System (K031571) (K063029) EmpowerCT Injector System (K011160) (K063029) New Indications for Use: The EmpowerCTA Injector syst… | 2006 |
| * | K011160 | E-Z EM Percupump 2001 CT InjectorSummary page 1…50 (Product Code IZQ) Currently Marketed Devices: EmpowerCTA Injector System (K031571) (K063029) EmpowerCT Injector System (K011160) (K063029) New Indications for Use: The EmpowerCTA Injector system is intended for the vascular admi… | 2001 |
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 |
|---|---|---|---|
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | 2026 | 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 6 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K262115 (ACIST Medical Systems, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K031571.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner
The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071378 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071378: Modification to Empower CT/Cta Injector System, Models 9800/9900 Product Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071378
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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