510(k) · Cleared
ClearedAcist Angiographic Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invasatec · DXT Injector And Syringe, Angiographic
Cleared on Dec 5, 1997 as substantially equivalent to K822536 (Medrad, Inc., 1982) after a 429-day review. Its family tree reaches back 1 generation to 1982. 23 later devices descend from it.
- Decided
- Dec 5, 1997
- Review
- 429 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K822536 (1982). 23 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK822536 MARK VMedrad, Inc. · 1982
- This deviceK963982 Acist Angiographic InjectorInvasatec · 1997
- Descendant · cites it directly · 20 of its ownK984231 Angiographic Contrast Management System, Model Part a and Part BInvasatec · 2000 · Recalled
- Descendant · cites it directly · 20 of its ownK984058 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 · 14 of its ownK052744 C2000 Automated Manifold KitAcist Medical Systems, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 13 of its ownK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K984231Angiographic Contrast Management System, Model Part a and Part BInvasatec · 2000 · cites it directly20descendants
- K984058Acist Injector System, Model CL100 HAcist Medical Systems · 1999 · cites it directly20descendants
- K991103Modification to Acist CL 100HAcist Medical Systems · 2000 · cites it directly19descendants
- K052744C2000 Automated Manifold KitAcist Medical Systems, Inc. · 2005 · 2 generations on14descendants
- K131478Contrast Conservation SystemOsprey Medical, Inc. · 2013 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822536 | MARK V | Medrad, Inc. | 1982 | — |
| 0 (this device) | K963982 | Acist Angiographic Injector | Invasatec | 1997 | — |
| +1 | K984231 | Angiographic Contrast Management System, Model Part a and Part B | Invasatec | 2000 | 4 |
| +1 | K984058 | Acist Injector System, Model CL100 H | Acist Medical Systems | 1999 | — |
| +1 | K991103 | Modification to Acist CL 100H | Acist Medical Systems | 2000 | 3 |
| +2 | K052744 | C2000 Automated Manifold Kit | Acist Medical Systems, Inc. | 2005 | 1 |
| +2 | K131478 | Contrast Conservation System | Osprey Medical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 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 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 |
|---|---|---|---|
| * | K822536 | MARK VSummary page 2…ubmitter Invasatec Corporation 10180 Viking Drive Eden Prairie, MN 55344 (612) 941-3507 Contact Doug Duchon Vice President Predicate Devices Mark V from Medrad, Inc. K822536. Mark V+ from Medrad, Inc. Device Description The ACIST is an angiographic injector system which supplies radiographic contrast… | 1982 |
| * | — | Mark V+ Named without a submission number |
What descends from it? (23)
See all 233 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 System from Invasatec 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/K963982 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963982: Acist Angiographic Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963982
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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