510(k) · Cleared
ClearedACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acist Medical Systems, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Jul 18, 2019 as substantially equivalent to K171646 (Acist Medical Systems, Inc., 2018) after an 87-day review. Its family tree reaches back 5 generations to 1982. 2 later devices descend from it.
- Decided
- Jul 18, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K822536 (1982). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK822536 MARK VMedrad, Inc. · 1982
- 4 generations backK963982 Acist Angiographic InjectorInvasatec · 1997
- 3 generations backK984058 Acist Injector System, Model CL100 HAcist Medical Systems · 1999
- 2 generations backK991103 Modification to Acist CL 100HAcist Medical Systems · 2000 · Recalled
- 1 generation backK171646 ACISTCVi® Contrast Delivery SystemAcist Medical Systems, Inc. · 2018
- This deviceK191060 ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V…Acist Medical Systems, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK203004 ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery…Acist Medical Systems, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK252638 VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low…Acist Medical Systems, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K822536 | MARK V | Medrad, Inc. | 1982 | — |
| −4 | K963982 | Acist Angiographic Injector | Invasatec | 1997 | — |
| −3 | K984058 | Acist Injector System, Model CL100 H | Acist Medical Systems | 1999 | — |
| −2 | K991103 | Modification to Acist CL 100H | Acist Medical Systems | 2000 | 3 |
| −1 | K171646 | ACISTCVi® Contrast Delivery System | Acist Medical Systems, Inc. | 2018 | — |
| 0 (this device) | K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit… | Acist Medical Systems, Inc. | 2019 | — |
| +1 | K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | Acist Medical Systems, Inc. | 2020 | — |
| +2 | K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity… | Acist Medical Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2026 | 1 | 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? (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 |
|---|---|---|---|
| * | K171646 | ACISTCVi® Contrast Delivery SystemSummary page 4…Contrast Delivery System Product Code DXT Classification Class II, 21 CFR Part 870.1650, Angiographic injector and syringe Predicate Device K171646 ACIST | CVi® Contrast Delivery System Device Description The ACIST | CVi1 Contrast Delivery System is designed to aid the… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | 2020 | 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 37 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K203004 (Acist Medical Systems, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K171646.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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|CVi®1 Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The CVi1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CVi1 Syringe Kits are also indicated for single patient use with ACIST|CVi® Contrast Delivery Systems. The ACIST|CVi®1 Contrast Delivery System is to…
Read the full statement (99 words)
The ACIST|CVi®1 Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures.
The CVi1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CVi1 Syringe Kits are also indicated for single patient use with ACIST|CVi® Contrast Delivery Systems.
The ACIST|CVi®1 Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191060: ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191060
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