510(k) · Cleared
Recalled · Class II · 2015Angiographic Contrast Management System, Model Part a and Part B
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 May 31, 2000 as substantially equivalent to K963982 (Invasatec, 1997) and 2 other predicates after a 553-day review. Its family tree reaches back 2 generations to 1991. 20 later devices descend from it. It has been recalled 4 times.
- Decided
- May 31, 2000
- Review
- 553 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 2 generations to K903493 (1991). 4 ancestors in all, the oldest K822536 (1982). 20 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
- 1 generation backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
- This deviceK984231 Angiographic Contrast Management System, Model Part a and Part BInvasatec · 2000
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 12 of its ownK140425 Contrast Modulation SystemOsprey Medical, Inc. · 2014
- Descendant · 4 generations on · 10 of its ownK150485 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- Descendant · 4 generations on · 8 of its ownK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K052744C2000 Automated Manifold KitAcist Medical Systems, Inc. · 2005 · cites it directly14descendants
- K131478Contrast Conservation SystemOsprey Medical, Inc. · 2013 · 2 generations on13descendants
- K140425Contrast Modulation SystemOsprey Medical, Inc. · 2014 · 3 generations on12descendants
- K150485AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015 · 4 generations on10descendants
- K151300AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| −1 | K961794 | Fluid Administration Set - Contrast Manager | Merit Medical Systems, Inc. | 1996 | — |
| 0 (this device) | K984231 | Angiographic Contrast Management System, Model Part a and Part B | Invasatec | 2000 | — |
| +1 | K052744 | C2000 Automated Manifold Kit | Acist Medical Systems, Inc. | 2005 | 1 |
| +2 | K131478 | Contrast Conservation System | Osprey Medical, Inc. | 2013 | — |
| +3 | K140425 | Contrast Modulation System | Osprey Medical, Inc. | 2014 | — |
| +4 | K150485 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| +4 | K151300 | AVERT 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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K963982 | Acist Angiographic Injector Our OCR of the scanned summary read K963882, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Acist Injection System”. | 1997 |
| * | K961794 | Fluid Administration Set - Contrast ManagerSummary page 1…5344 612-941-3507 Contact Kate Anderson Manager, QA/Regulatory Predicate Devices Acist Injection System (K963882) ACIST Medical Systems Merit Contrast Management System (K961794) Merit Medical Systems, Inc. NAMIC Contrast Saving Delivery System (K903493) North American Instrument Corporation, Angiographic… | 1996 |
| * | K903493 | Namic Contrast Savings Delivery SystemSummary page 1…ices Acist Injection System (K963882) ACIST Medical Systems Merit Contrast Management System (K961794) Merit Medical Systems, Inc. NAMIC Contrast Saving Delivery System (K903493) North American Instrument Corporation, Angiographic System Division Device Description The ACIST Medical Systems Angiographic C… | 1991 |
What descends from it? (20)
See all 202 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)
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. |
| Oct 3, 2007 | Not classified | Z-0359-2008 | Process design | Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture. |
| May 19, 2004 | Not classified | Z-1002-04 | Other | Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile. |
| Oct 2, 2003 | Not classified | Z-0064-04 | Other | Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K052744 (Acist Medical Systems, Inc., 2005) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K963982.
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 ™ CMS-2000 Angiographic Injection System with Contrast Management 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/K984231 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984231: Angiographic Contrast Management System, Model Part a and Part B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984231
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