510(k) · Cleared

Cleared

Empower CT/Cta Injector System, Model 9800/9900

K063029510(k) SpecialCleared Nov 2, 200631-day reviewClass II21 CFR 892.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

E-Z-Em, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Nov 2, 2006 as substantially equivalent to K011160 (E-Z-Em, Inc., 2001) and 1 other predicate after a 31-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.

Decided: Nov 2, 2006
Review: 31 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K011160 (2001). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK011160 E-Z EM Percupump 2001 CT InjectorE-Z-Em, Inc. · 2001 · Recalled
1 generation backK031571 Empowercta Injector System, Models 9930 & 9910 & 9825E-Z-Em, Inc. · 2003 · Recalled
This deviceK063029 Empower CT/Cta Injector System, Model 9800/9900E-Z-Em, Inc. · 2006
Descendant · cites it directly · 1 of its ownK071378 Modification to Empower CT/Cta Injector System, Models 9800/9900…E-Z-Em, Inc. · 2007
Descendant · 2 generations on · 0 of its ownK262115 VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc. · 2026

Most influential descendants

Showing 2 of 2 · See all

K071378Modification to Empower CT/Cta Injector System, Models 9800/9900 Product SeriesE-Z-Em, Inc. · 2007 · cites it directly1descendant
K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc. · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K011160	E-Z EM Percupump 2001 CT Injector	E-Z-Em, Inc.	2001	3
−1	K031571	Empowercta Injector System, Models 9930 & 9910 & 9825	E-Z-Em, Inc.	2003	3
0 (this device)	K063029	Empower CT/Cta Injector System, Model 9800/9900	E-Z-Em, Inc.	2006	—
+1	K071378	Modification to Empower CT/Cta Injector System, Models 9800/9900 Product Series	E-Z-Em, Inc.	2007	—
+2	K262115	VueJect® Ultrasound Enhancing Agent Delivery System	ACIST Medical Systems, Inc.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2026	1	0

FIG. 1 — Lineage of K063029, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K011160	E-Z EM Percupump 2001 CT Injector Summary page 1 …50 (Product Code IZO) Currently Marketed Devices: E-Z-EM EmpowerCTA Injector System (K031571) EmpowerCT Injector System (K1011160) New Indications for Use: The EmpowerCTA Injector system is intended for the vascular administratio…	E-Z-Em, Inc.	2001	3
*	K031571	Empowercta Injector System, Models 9930 & 9910 & 9825 Summary page 1 ….2770 (Product Code DSB) 21 CFR 870.1650 (Product Code IZO) Currently Marketed Devices: E-Z-EM EmpowerCTA Injector System (K031571) EmpowerCT Injector System (K1011160) New Indications for Use: The EmpowerCTA Injector system is in…	E-Z-Em, Inc.	2003	3

Also cleared against K011160: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071378	Modification to Empower CT/Cta Injector System, Models 9800/9900 Product Series	E-Z-Em, Inc.	2007	1

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 5 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
2 of the 2 ancestors have a recall of any class.
Of its descendants, K071378 (E-Z-Em, Inc., 2007) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K011160.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)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/K063029 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063029: Empower CT/Cta Injector System, Model 9800/9900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063029

Report an extraction error

Are you the manufacturer?

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