510(k) · Cleared
ClearedACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
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 Dec 17, 2020 as substantially equivalent to K191060 (Acist Medical Systems, Inc., 2019) after a 77-day review. Its family tree reaches back 6 generations to 1982. 1 later device descends from it.
- Decided
- Dec 17, 2020
- Review
- 77 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K822536 (1982). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK822536 MARK VMedrad, Inc. · 1982
- 5 generations backK963982 Acist Angiographic InjectorInvasatec · 1997
- 4 generations backK984058 Acist Injector System, Model CL100 HAcist Medical Systems · 1999
- 3 generations backK991103 Modification to Acist CL 100HAcist Medical Systems · 2000 · Recalled
- 2 generations backK171646 ACISTCVi® Contrast Delivery SystemAcist Medical Systems, Inc. · 2018
- 1 generation backK191060 ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V…Acist Medical Systems, Inc. · 2019
- This deviceK203004 ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery…Acist Medical Systems, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK252638 VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low…Acist Medical Systems, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…Acist Medical Systems, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K822536 | MARK V | Medrad, Inc. | 1982 | — |
| −5 | K963982 | Acist Angiographic Injector | Invasatec | 1997 | — |
| −4 | K984058 | Acist Injector System, Model CL100 H | Acist Medical Systems | 1999 | — |
| −3 | K991103 | Modification to Acist CL 100H | Acist Medical Systems | 2000 | 3 |
| −2 | K171646 | ACISTCVi® Contrast Delivery System | Acist Medical Systems, Inc. | 2018 | — |
| −1 | K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit… | Acist Medical Systems, Inc. | 2019 | — |
| 0 (this device) | K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | Acist Medical Systems, Inc. | 2020 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000…Summary page 4…Product Code DXT Classification Class II, 21 CFR Part 870.1650, Angiographic injector and syringe Predicate Device ACIST CVi®/CVi®1 Contrast Delivery System (K191060) Device The CVi/CVi1 System is designed to aid the physician in the controlled Description infusion of radio… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use… | 2026 | 0 |
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 38 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K252638 (Acist Medical Systems, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
ACIST CVi®1 Contrast Delivery System 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 CVi®1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CVi®1 Syringe Kits are also indicated for single patient use with ACIST CVi® Contrast Delivery Systems. The…
Read the full statement (243 words)
ACIST CVi®1 Contrast Delivery System
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 CVi®1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CVi®1 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.
ACIST CVi® Contrast Delivery System
The ACIST CVi® Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The ACIST CVi® Contrast Delivery System is specifically indicated for use in angiographic procedures for the delivery of ISOVUE (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of ten (10) hours. The Syringe Kit must be discarded after six (6) patient procedures. The Manifold Kit and AngioTouch Hand Controller Kit must be discarded after each patient procedure. The ACIST CVi® 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/K203004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203004: ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203004
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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