510(k) · Cleared
Recalled · 2008Modification to Acist CL 100H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acist Medical Systems · DXT Injector And Syringe, Angiographic
Cleared on May 31, 2000 as substantially equivalent to K963982 (Invasatec, 1997) and 1 other predicate after a 426-day review. Its family tree reaches back 3 generations to 1982. 19 later devices descend from it. It has been recalled 3 times.
- Decided
- May 31, 2000
- Review
- 426 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K822536 (1982). 19 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK822536 MARK VMedrad, Inc. · 1982
- 2 generations backK963982 Acist Angiographic InjectorInvasatec · 1997
- 1 generation backK984058 Acist Injector System, Model CL100 HAcist Medical Systems · 1999
- This deviceK991103 Modification to Acist CL 100HAcist Medical Systems · 2000
- Descendant · cites it directly · 13 of its ownK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
- Descendant · 2 generations on · 12 of its ownK140425 Contrast Modulation SystemOsprey Medical, Inc. · 2014
- Descendant · 3 generations on · 10 of its ownK150485 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- Descendant · 3 generations on · 8 of its ownK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- Descendant · 3 generations on · 8 of its ownK151746 Dyevert Contrast Modulation SystemOsprey Medical, Inc. · 2015
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K131478Contrast Conservation SystemOsprey Medical, Inc. · 2013 · cites it directly13descendants
- K140425Contrast Modulation SystemOsprey Medical, Inc. · 2014 · 2 generations on12descendants
- K150485AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015 · 3 generations on10descendants
- K151300AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015 · 3 generations on8descendants
- K151746Dyevert Contrast Modulation SystemOsprey Medical, Inc. · 2015 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K822536 | MARK V | Medrad, Inc. | 1982 | — |
| −2 | K963982 | Acist Angiographic Injector | Invasatec | 1997 | — |
| −1 | K984058 | Acist Injector System, Model CL100 H | Acist Medical Systems | 1999 | — |
| 0 (this device) | K991103 | Modification to Acist CL 100H | Acist Medical Systems | 2000 | — |
| +1 | K131478 | Contrast Conservation System | Osprey Medical, Inc. | 2013 | — |
| +2 | K140425 | Contrast Modulation System | Osprey Medical, Inc. | 2014 | — |
| +3 | K150485 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| +3 | K151300 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| +3 | K151746 | Dyevert Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DXT? 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 DXT device
- #1 K253048 High Pressure Syringe; Pressure Connecting…score 13.6 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K963982 | Acist Angiographic InjectorSummary page 1…rive Eden Prairie, MN 55344 (612) 941-3507 Contact Ed Miller Vice President, Operations Predicate Devices Angiographic Injector System from Acist Medical Models CL100 #K963982 CL100H #K984058 Device Description This device is a variation of the Acist Angiographic Injector System (CL100 & CL100H). The C… | 1997 |
| * | K984058 | Acist Injector System, Model CL100 HSummary page 1…ie, MN 55344 (612) 941-3507 Contact Ed Miller Vice President, Operations Predicate Devices Angiographic Injector System from Acist Medical Models CL100 #K963982 CL100H #K984058 Device Description This device is a variation of the Acist Angiographic Injector System (CL100 & CL100H). The CMS2000 is design… | 1999 |
What descends from it? (19)
See all 192 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 10, 2008 | Not classified | Z-0643-2009 | Software design | Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in… |
| May 19, 2004 | Not classified | Z-1002-04 | Other | Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile. |
| Oct 2, 2003 | Not classified | Z-0064-04 | Other | Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K131478 (Osprey Medical, Inc., 2013) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K963982.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXT
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXT
10in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXT
97in 2025
MAUDE reports naming product code DXT, 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 | 182 | 4 | 107 |
| 2008 | 2 | — | 3 | 168 |
| 2009 | 6 | 137 | 7 | 188 |
| 2010 | 1 | — | 3 | 124 |
| 2011 | 4 | 69 | 3 | 133 |
| 2012 | 0 | — | 7 | 135 |
| 2013 | 2 | — | 0 | 141 |
| 2014 | 6 | 144 | 0 | 97 |
| 2015 | 7 | 153 | 1 | 135 |
| 2016 | 8 | 172 | 0 | 152 |
| 2017 | 7 | 183 | 0 | 128 |
| 2018 | 9 | 93 | 2 | 129 |
| 2019 | 4 | 96 | 0 | 121 |
| 2020 | 3 | 154 | 1 | 93 |
| 2021 | 1 | — | 1 | 132 |
| 2022 | 0 | — | 0 | 111 |
| 2023 | 1 | — | 2 | 117 |
| 2024 | 4 | 138 | 10 | 118 |
| 2025 | 1 | — | 0 | 97 |
| 2026 | 7 | 264 | 6 | — |
What is it indicated for?
The Acist ™ CMS-2000 Angiographic Injection System with Contrast Management is intended to be used for the controlled infusion of radiopaque 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/K991103 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991103: Modification to Acist CL 100H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991103
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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