510(k) · Cleared
ClearedAcist Injector System, Model CL100 H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acist Medical Systems · IZQ Injector, Contrast Medium, Automatic
Cleared on Feb 11, 1999 as substantially equivalent to K963982 (Invasatec, 1997) after a 90-day review. Its family tree reaches back 2 generations to 1982. 20 later devices descend from it.
- Decided
- Feb 11, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- IZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K822536 (1982). 20 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK822536 MARK VMedrad, Inc. · 1982
- 1 generation backK963982 Acist Angiographic InjectorInvasatec · 1997
- This deviceK984058 Acist Injector System, Model CL100 HAcist Medical Systems · 1999
- Descendant · cites it directly · 19 of its ownK991103 Modification to Acist CL 100HAcist Medical Systems · 2000 · Recalled
- Descendant · 2 generations on · 13 of its ownK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
- Descendant · 3 generations on · 12 of its ownK140425 Contrast Modulation SystemOsprey Medical, Inc. · 2014
- Descendant · 4 generations on · 10 of its ownK150485 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- Descendant · 4 generations on · 8 of its ownK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K991103Modification to Acist CL 100HAcist Medical Systems · 2000 · cites it directly19descendants
- K131478Contrast Conservation SystemOsprey Medical, Inc. · 2013 · 2 generations on13descendants
- K140425Contrast Modulation SystemOsprey Medical, Inc. · 2014 · 3 generations on12descendants
- K150485AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015 · 4 generations on10descendants
- K151300AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K822536 | MARK V | Medrad, Inc. | 1982 | — |
| −1 | K963982 | Acist Angiographic Injector | Invasatec | 1997 | — |
| 0 (this device) | K984058 | Acist Injector System, Model CL100 H | Acist Medical Systems | 1999 | — |
| +1 | K991103 | Modification to Acist CL 100H | Acist Medical Systems | 2000 | 3 |
| +2 | K131478 | Contrast Conservation System | Osprey Medical, Inc. | 2013 | — |
| +3 | K140425 | Contrast Modulation System | Osprey Medical, Inc. | 2014 | — |
| +4 | K150485 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| +4 | K151300 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2026 | 2 | 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 IZQ? 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 IZQ device
- #1 K241850 ulricheasyINJECT Max 2M (XD 10140)…score 12.7 · 7 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 |
|---|---|---|---|
| * | K963982 | Acist Angiographic InjectorSummary page 1…alley View Drive Eden Prairie, MN 55344 (612) 941-3507 Contact Kate Anderson Manager, QA/regulatory Predicate Devices Angiographic Injector System from Acist Medical. K963982 Device Description This device is a modification to the Acist Angiographic Injector System. The modification is a means to use… | 1997 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991103 | Modification to Acist CL 100H | 2000 | 19 |
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 17 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K991103 (Acist Medical Systems, 2000) has gone furthest, with 19 descendants of its own.
- 2 other devices also cite its predicate K963982.
How does its category compare?
All IZQ devicesIZQ Injector, Contrast Medium, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZQ
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZQ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZQ
21in 2025
MAUDE reports naming product code IZQ, 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 | 3 | 168 | 0 | 14 |
| 2008 | 0 | — | 1 | 72 |
| 2009 | 0 | — | 0 | 48 |
| 2010 | 1 | — | 0 | 42 |
| 2011 | 0 | — | 2 | 41 |
| 2012 | 0 | — | 0 | 23 |
| 2013 | 0 | — | 0 | 23 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 1 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 3 | 131 | 0 | 23 |
| 2025 | 3 | 119 | 0 | 21 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ACIST System from Invasatec is intended to be used for the controlled infusion of radio-opaque contrast media for angiographic procedures.
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/K984058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984058: Acist Injector System, Model CL100 H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984058
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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