510(k) · Cleared
ClearedDyeVert PLUS EZ Contrast Reduction 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 Oct 25, 2018 as substantially equivalent to K163054 (Osprey Medical, Inc., 2017) after a 98-day review. Its family tree reaches back 11 generations to 1982. 2 later devices descend from it.
- Decided
- Oct 25, 2018
- Review
- 98 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K822536 (1982). 20 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK822536 MARK VMedrad, Inc. · 1982
- 7 generations between
- 3 generations backK153141 DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016
- 2 generations backK161505 DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016
- 1 generation backK163054 DyeVert Plus Contrast Modulation/Monitoring System, Contrast…Osprey Medical, Inc. · 2017
- This deviceK181936 DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK190102 DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast…Osprey Medical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK183267 DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast…Osprey Medical, Inc. · 2018
Show all 11 generations
- Root · 11 generations backK822536 MARK VMedrad, Inc. · 1982
- 10 generations backK963982 Acist Angiographic InjectorInvasatec · 1997
- 9 generations backK984058 Acist Injector System, Model CL100 HAcist Medical Systems · 1999
- 8 generations backK991103 Modification to Acist CL 100HAcist Medical Systems · 2000 · Recalled
- 7 generations backK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
- 6 generations backK140425 Contrast Modulation SystemOsprey Medical, Inc. · 2014
- 5 generations backK150485 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- 4 generations backK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- 3 generations backK153141 DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016
- 2 generations backK161505 DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016
- 1 generation backK163054 DyeVert Plus Contrast Modulation/Monitoring System, Contrast…Osprey Medical, Inc. · 2017
- This deviceK181936 DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See all- K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™…Osprey Medical, Inc. · 2019 · cites it directly0descendants
- K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System…Osprey Medical, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K822536 | MARK V | Medrad, Inc. | 1982 | — |
| −10 | K963982 | Acist Angiographic Injector | Invasatec | 1997 | — |
| −9 | K984058 | Acist Injector System, Model CL100 H | Acist Medical Systems | 1999 | — |
| −8 | K991103 | Modification to Acist CL 100H | Acist Medical Systems | 2000 | 3 |
| −7 | K131478 | Contrast Conservation System | Osprey Medical, Inc. | 2013 | — |
| −6 | K140425 | Contrast Modulation System | Osprey Medical, Inc. | 2014 | — |
| −5 | K150485 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| −4 | K151300 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| −3 | K153141 | DyeVert Contrast Modulation System | Osprey Medical, Inc. | 2016 | — |
| −2 | K161505 | DyeVert NG Contrast Modulation System | Osprey Medical, Inc. | 2016 | — |
| −1 | K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System | Osprey Medical, Inc. | 2017 | — |
| 0 (this device) | K181936 | DyeVert PLUS EZ Contrast Reduction System | Osprey Medical, Inc. | 2018 | — |
| +1 | K190102 | DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System… | Osprey Medical, Inc. | 2019 | — |
| +1 | K183267 | DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction… | Osprey Medical, Inc. | 2018 | — |
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 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemSummary page 5…II CFR Reference: 21 CFR § 870.1650 Product Code: DXT 510(k) number(s) K163054 Comparison to the Predicate Device: The proposed device is substantially equivalent to the previously cleared predicate, in that… | 2017 |
What descends from it? (2)
2 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 36 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K190102 (Osprey Medical, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K163054.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 device consists of a display to be used with the DyeVert Plus Disposable Kit, DyeVert Plus EZ Disposable Kit or the DyeTect Contrast Monitoring Disposable Kit during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.
The DyeVert™ Plus EZ Contrast Reduction System consists of a Display and DyeVert Plus EZ Disposable Kit. The system is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT 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 as stated in the FDA summary.
https://510kreport.com/device/K181936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181936: DyeVert PLUS EZ Contrast Reduction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181936
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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