510(k) · Cleared
ClearedACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable
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 May 13, 2026 as substantially equivalent to K171646 (Acist Medical Systems, Inc., 2018) after a 264-day review. Its family tree reaches back 5 generations to 1982.
- Decided
- May 13, 2026
- Review
- 264 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. No later device cites it as a predicate yet.
- 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 deviceK252653 ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount…Acist Medical Systems, Inc. · 2026
View 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) | K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch… | 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 |
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 5…ion Name: Angiographic Injector and syringe (21 CFR 870.1650) Regulatory Class: II Product Code: DXT 3. Predicate Device ACIST CVi® Contrast Delivery System, K171646 4. Device Description The ACIST Pro™ Diagnostic System is an angiographic injection system used in interventional cardiology, r… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 44 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 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. 2026, 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 Pro Diagnostic System is indicated for controlled administration of radiopaque contrast media and saline to human subjects undergoing angiographic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252653 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252653: ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252653
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026