510(k) · Cleared
ClearedContrast Modulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osprey Medical, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Jun 11, 2014 as substantially equivalent to K131478 (Osprey Medical, Inc., 2013) after a 112-day review. Its family tree reaches back 5 generations to 1982. 12 later devices descend from it.
- Decided
- Jun 11, 2014
- Review
- 112 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K822536 (1982). 12 ancestors in all. 12 later devices descend from it, 4 citing it directly.
- 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 backK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
- This deviceK140425 Contrast Modulation SystemOsprey Medical, Inc. · 2014
- Descendant · cites it directly · 10 of its ownK150485 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- Descendant · cites it directly · 8 of its ownK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- Descendant · cites it directly · 8 of its ownK151746 Dyevert Contrast Modulation SystemOsprey Medical, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK153141 DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016
- Descendant · 3 generations on · 6 of its ownK161505 DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K150485AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015 · cites it directly10descendants
- K151300AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015 · cites it directly8descendants
- K151746Dyevert Contrast Modulation SystemOsprey Medical, Inc. · 2015 · cites it directly8descendants
- K153141DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016 · 2 generations on7descendants
- K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016 · 3 generations on6descendants
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 | K131478 | Contrast Conservation System | Osprey Medical, Inc. | 2013 | — |
| 0 (this device) | K140425 | Contrast Modulation System | Osprey Medical, Inc. | 2014 | — |
| +1 | K150485 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| +1 | K151300 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| +1 | K151746 | Dyevert Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| +2 | K153141 | DyeVert Contrast Modulation System | Osprey Medical, Inc. | 2016 | — |
| +3 | K161505 | DyeVert NG Contrast Modulation System | Osprey Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K131478 | Contrast Conservation SystemSummary page 1…lation System is substantially equivalent in intended use, method of operation and technical aspects to the first generation AVERT Contrast Modulation System (weighted) (K 13 1478). The AVERT Contrast Modulation System is also similar to the Acist Angiographic Injection System (K993774, K091 103, and K000013… | 2013 |
| † | K993774 | Acist Angiographic Injection System, Model CL1OOH | 1999 |
| † | K091103 | Guideshot Option for CXR4 and Eclos CT Systems | 2009 |
| † | K000013 | Acist Angiographic Injection System, Model R-2000 | 2000 |
| † | K052744 | C2000 Automated Manifold Kit | 2005 |
| † | K093830 | Medline Angiographic Control Syringe | 2011 |
What descends from it? (12)
See all 124 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?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K150485 (Osprey Medical, Inc., 2015) has gone furthest, with 10 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. 2014, 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 AVERT Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: lodixanol 270 or 320 mgl/ml, lohexol 300 or 350 mgl/ml, and lopamidol 370 mgI/ml.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140425: Contrast Modulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140425
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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