510(k) · Cleared
Recalled · Class II · 2015C2000 Automated Manifold 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 Dec 16, 2005 as substantially equivalent to K984231 (Invasatec, 2000) after a 77-day review. Its family tree reaches back 3 generations to 1991. 14 later devices descend from it. It has been recalled once.
- Decided
- Dec 16, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K903493 (1991). 5 ancestors in all, the oldest K822536 (1982). 14 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
- 2 generations backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
- 1 generation backK984231 Angiographic Contrast Management System, Model Part a and Part BInvasatec · 2000 · Recalled
- This deviceK052744 C2000 Automated Manifold KitAcist Medical Systems, Inc. · 2005
- 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 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · 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 | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| −2 | K961794 | Fluid Administration Set - Contrast Manager | Merit Medical Systems, Inc. | 1996 | — |
| −1 | K984231 | Angiographic Contrast Management System, Model Part a and Part B | Invasatec | 2000 | 4 |
| 0 (this device) | K052744 | C2000 Automated Manifold Kit | Acist Medical Systems, Inc. | 2005 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1997 | 1 | 0 |
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 | 2 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K984231 | Angiographic Contrast Management System, Model Part a and Part BSummary page 1…ially, equivalent to thei predicate device, ACIST Anogroaphic Coiuuaat Management System (cleared under K98423 1) This conclusion is based uponi the similarities of the devices in terms of functional design, i… | 2000 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131478 | Contrast Conservation System | 2013 | 13 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2015 | Class II | Z-0744-2016 | Nonconforming Material/Component | Reports related to ingress of air into the manifold. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K131478 (Osprey Medical, Inc., 2013) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K984231.
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 Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052744 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052744: C2000 Automated Manifold Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052744
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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