510(k) · Cleared
ClearedAcist Angiographic Injection System, Model CL1OOH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acist Medical Systems · DXT Injector And Syringe, Angiographic
Cleared on Dec 7, 1999 after a 29-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Dec 7, 1999
- Review
- 29 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK993774 Acist Angiographic Injection System, Model CL1OOHAcist Medical Systems · 1999
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K993774 | Acist Angiographic Injection System, Model CL1OOH | Acist Medical Systems | 1999 | — |
| +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 | — |
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 |
|---|---|---|---|
| * | — | Acist® Angiographic Injection System, Model CL100H without the “RESUME?” feature Named without a submission number |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K131478 (Osprey Medical, Inc., 2013) has gone furthest, with 13 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 | — |
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993774 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993774: Acist Angiographic Injection System, Model CL1OOH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993774
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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