510(k) Report

510(k) · Cleared

Recalled · 2004

E-Z EM Percupump 2001 CT Injector

K011160510(k) SpecialCleared May 16, 200130-day reviewClass II21 CFR 892.1750Recalls 3

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 May 16, 2001 after a 30-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled 3 times.

Decided
May 16, 2001
Review
30 days
Class
Class II
Product code
JAK
Recalls
3
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2007: 1 descendant cleared2006: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK011160 E-Z EM Percupump 2001 CT InjectorE-Z-Em, Inc. · 2001
  2. Descendant · cites it directly · 3 of its ownK031571 Empowercta Injector System, Models 9930 & 9910 & 9825E-Z-Em, Inc. · 2003 · Recalled
  3. Descendant · cites it directly · 2 of its ownK063029 Empower CT/Cta Injector System, Model 9800/9900E-Z-Em, Inc. · 2006
  4. Descendant · cites it directly · 1 of its ownK071378 Modification to Empower CT/Cta Injector System, Models 9800/9900…E-Z-Em, Inc. · 2007
  5. Descendant · 2 generations on · 0 of its ownK262115 VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc. · 2026

Most influential descendants

Showing 4 of 4 · See all
  • K031571Empowercta Injector System, Models 9930 & 9910 & 9825E-Z-Em, Inc. · 2003 · cites it directly3descendants
  • K063029Empower CT/Cta Injector System, Model 9800/9900E-Z-Em, Inc. · 2006 · cites it directly2descendants
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011160E-Z EM Percupump 2001 CT InjectorE-Z-Em, Inc.2001—
+1K031571Empowercta Injector System, Models 9930 & 9910 & 9825E-Z-Em, Inc.20033
+1K063029Empower CT/Cta Injector System, Model 9800/9900E-Z-Em, Inc.2006—
+1K071378Modification to Empower CT/Cta Injector System, Models 9800/9900 Product SeriesE-Z-Em, Inc.2007—
+2K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200710
202610
FIG. 1 — Lineage of K011160, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031571Empowercta Injector System, Models 9930 & 9910 & 9825E-Z-Em, Inc.20033
K063029Empower CT/Cta Injector System, Model 9800/9900E-Z-Em, Inc.20062
K071378Modification to Empower CT/Cta Injector System, Models 9800/9900 Product SeriesE-Z-Em, Inc.20071

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 3, 2004Not classifiedZ-0548-05OtherOut of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.
Dec 3, 2004Not classifiedZ-0549-05OtherOut of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.
Dec 3, 2004Not classifiedZ-0550-05OtherOut of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K031571 (E-Z-Em, Inc., 2003) has gone furthest, with 3 descendants of its own.

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

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

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

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
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

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

More from E-Z-Em, Inc.

56 FDA decisions under this applicant name. See the company

  • K071378Modification to Empower CT/Cta Injector System, Models 9800/9900 Product SeriesE-Z-Em, Inc. · 2007
  • K062449Empowermr Injector System, Model 9730E-Z-Em, Inc. · 2007
  • K063029Empower CT/Cta Injector System, Model 9800/9900E-Z-Em, Inc. · 2006
  • K053008E-Z-EM Endoscopic CO2 RegulatorE-Z-Em, Inc. · 2005
  • K041178Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc. · 2004

Recent decisions in JAK

The JAK category page

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  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
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https://510kreport.com/device/K011160 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011160: E-Z EM Percupump 2001 CT Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011160

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026