510(k) · Cleared
ClearedDyeVert Contrast 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 Feb 4, 2016 as substantially equivalent to K151746 (Osprey Medical, Inc., 2015) and 1 other predicate after a 97-day review. Its family tree reaches back 8 generations to 1982. 7 later devices descend from it.
- Decided
- Feb 4, 2016
- Review
- 97 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K822536 (1982). 16 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK822536 MARK VMedrad, Inc. · 1982
- 7 generations backK963982 Acist Angiographic InjectorInvasatec · 1997
- 6 generations backK984058 Acist Injector System, Model CL100 HAcist Medical Systems · 1999
- 5 generations backK991103 Modification to Acist CL 100HAcist Medical Systems · 2000 · Recalled
- 4 generations backK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
- 3 generations backK140425 Contrast Modulation SystemOsprey Medical, Inc. · 2014
- 2 generations backK150485 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- 1 generation backK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- This deviceK153141 DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK161505 DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK163054 DyeVert Plus Contrast Modulation/Monitoring System, Contrast…Osprey Medical, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK181936 DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK171698 Smart SyringeOsprey Medical, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK171217 DyeVert Plus Contrast Reduction System, DyeVert NG Contrast…Osprey Medical, Inc. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016 · cites it directly6descendants
- K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemOsprey Medical, Inc. · 2017 · 2 generations on5descendants
- K181936DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018 · 3 generations on2descendants
- K171698Smart SyringeOsprey Medical, Inc. · 2017 · 3 generations on1descendant
- K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemOsprey Medical, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K822536 | MARK V | Medrad, Inc. | 1982 | — |
| −7 | K963982 | Acist Angiographic Injector | Invasatec | 1997 | — |
| −6 | K984058 | Acist Injector System, Model CL100 H | Acist Medical Systems | 1999 | — |
| −5 | K991103 | Modification to Acist CL 100H | Acist Medical Systems | 2000 | 3 |
| −4 | K131478 | Contrast Conservation System | Osprey Medical, Inc. | 2013 | — |
| −3 | K140425 | Contrast Modulation System | Osprey Medical, Inc. | 2014 | — |
| −2 | K150485 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| −1 | K151300 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| 0 (this device) | K153141 | DyeVert Contrast Modulation System | Osprey Medical, Inc. | 2016 | — |
| +1 | K161505 | DyeVert NG Contrast Modulation System | Osprey Medical, Inc. | 2016 | — |
| +2 | K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System | Osprey Medical, Inc. | 2017 | — |
| +3 | K181936 | DyeVert PLUS EZ Contrast Reduction System | Osprey Medical, Inc. | 2018 | — |
| +3 | K171698 | Smart Syringe | Osprey Medical, Inc. | 2017 | — |
| +2 | K171217 | DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System | Osprey Medical, Inc. | 2017 | — |
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 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K151746 | Dyevert Contrast Modulation SystemSummary page 5…ion: II CFR Reference: 21 CFR § 870.1650 Product Code: DXT 510(k) number(s) K151746 Secondary Predicate Device: Trade Name/Proprietary Name: AVERT™ Contrast Modulation System Manufacturer:… | 2015 |
| * | K151300 | AVERT Contrast Modulation SystemSummary page 6…2 Product Code: DXT 510(k) number(s) K151300 Comparison to the Predicate Device: The DyeVert Contrast Modulation System is substantially equivalent to the previously cleare… | 2015 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161505 | DyeVert NG Contrast Modulation System | 2016 | 6 |
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 34 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K161505 (Osprey Medical, Inc., 2016) has gone furthest, with 6 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. 2016, 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 DyeVert™ Contrast Modulation System is to be used for the controlled infusion and contrast volume reduction of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mgI/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL.
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/K153141 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153141: DyeVert Contrast Modulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153141
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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