510(k) · Cleared
ClearedMARK V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Sep 28, 1982 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 44 later devices descend from it.
- Decided
- Sep 28, 1982
- Review
- 35 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 0
44 later devices descend from it, 2 citing it directly.
- This deviceK822536 MARK VMedrad, Inc. · 1982
- Descendant · cites it directly · 23 of its ownK963982 Acist Angiographic InjectorInvasatec · 1997
- Descendant · 2 generations on · 20 of its ownK984231 Angiographic Contrast Management System, Model Part a and Part BInvasatec · 2000 · Recalled
- Descendant · 2 generations on · 20 of its ownK984058 Acist Injector System, Model CL100 HAcist Medical Systems · 1999
- Descendant · 2 generations on · 19 of its ownK991103 Modification to Acist CL 100HAcist Medical Systems · 2000 · Recalled
- Descendant · cites it directly · 19 of its ownK973334 OZ Power SyringeCardiovascular Innovations · 1998 · Recalled
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K963982Acist Angiographic InjectorInvasatec · 1997 · cites it directly23descendants
- K984231Angiographic Contrast Management System, Model Part a and Part BInvasatec · 2000 · 2 generations on20descendants
- K984058Acist Injector System, Model CL100 HAcist Medical Systems · 1999 · 2 generations on20descendants
- K991103Modification to Acist CL 100HAcist Medical Systems · 2000 · 2 generations on19descendants
- K973334OZ Power SyringeCardiovascular Innovations · 1998 · cites it directly19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K822536 | MARK V | Medrad, Inc. | 1982 | — |
| +1 | K963982 | Acist Angiographic Injector | Invasatec | 1997 | — |
| +2 | K984231 | Angiographic Contrast Management System, Model Part a and Part B | Invasatec | 2000 | 4 |
| +2 | K984058 | Acist Injector System, Model CL100 H | Acist Medical Systems | 1999 | — |
| +2 | K991103 | Modification to Acist CL 100H | Acist Medical Systems | 2000 | 3 |
| +1 | K973334 | OZ Power Syringe | Cardiovascular Innovations | 1998 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (44)
See all 442 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K963982 (Invasatec, 1997) has gone furthest, with 23 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.
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 | — |
https://510kreport.com/device/K822536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K822536: MARK V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822536
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026