510(k) · Cleared
ClearedDyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ 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 17, 2019 as substantially equivalent to K163054 (Osprey Medical, Inc., 2017) and 1 other predicate after a 268-day review. Its family tree reaches back 12 generations to 1982.
- Decided
- Oct 17, 2019
- Review
- 268 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K822536 (1982). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK822536 MARK VMedrad, Inc. · 1982
- 8 generations between
- 3 generations backK161505 DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016
- 2 generations backK163054 DyeVert Plus Contrast Modulation/Monitoring System, Contrast…Osprey Medical, Inc. · 2017
- 1 generation backK181936 DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018
- This deviceK190102 DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast…Osprey Medical, Inc. · 2019
Show all 12 generations
- Root · 12 generations backK822536 MARK VMedrad, Inc. · 1982
- 11 generations backK963982 Acist Angiographic InjectorInvasatec · 1997
- 10 generations backK984058 Acist Injector System, Model CL100 HAcist Medical Systems · 1999
- 9 generations backK991103 Modification to Acist CL 100HAcist Medical Systems · 2000 · Recalled
- 8 generations backK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
- 7 generations backK140425 Contrast Modulation SystemOsprey Medical, Inc. · 2014
- 6 generations backK150485 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- 5 generations backK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- 4 generations backK153141 DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016
- 3 generations backK161505 DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016
- 2 generations backK163054 DyeVert Plus Contrast Modulation/Monitoring System, Contrast…Osprey Medical, Inc. · 2017
- 1 generation backK181936 DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018
- This deviceK190102 DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast…Osprey Medical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K822536 | MARK V | Medrad, Inc. | 1982 | — |
| −11 | K963982 | Acist Angiographic Injector | Invasatec | 1997 | — |
| −10 | K984058 | Acist Injector System, Model CL100 H | Acist Medical Systems | 1999 | — |
| −9 | K991103 | Modification to Acist CL 100H | Acist Medical Systems | 2000 | 3 |
| −8 | K131478 | Contrast Conservation System | Osprey Medical, Inc. | 2013 | — |
| −7 | K140425 | Contrast Modulation System | Osprey Medical, Inc. | 2014 | — |
| −6 | K150485 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| −5 | K151300 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| −4 | K153141 | DyeVert Contrast Modulation System | Osprey Medical, Inc. | 2016 | — |
| −3 | 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 | — |
| −1 | K181936 | DyeVert PLUS EZ Contrast Reduction System | Osprey Medical, Inc. | 2018 | — |
| 0 (this device) | K190102 | DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System… | Osprey Medical, Inc. | 2019 | — |
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 |
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 |
|---|---|---|---|
| * | K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemSummary page 6…iographic injector and syringe Regulation: 21 CFR § 870.1650 Product Code: DXT 510(k) number(s) K163054 Trade Name/Proprietary Name: DyeVert™ Plus EZ Contrast Reduction System Manufacturer: Osprey… | 2017 |
| * | K181936 | DyeVert PLUS EZ Contrast Reduction SystemSummary page 6…iographic injector and syringe Regulation: 21 CFR § 870.1650 Product Code: DXT 510(k) number(s) K181936 Comparison to the Predicate Device: Comparison of Indications for use The proposed system’s Indications for Use are the same.… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 3 of the 21 ancestors have a recall of any class.
- 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. 2019, 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?
DyeVert™ Plus Contrast Reduction System Smart Monitor The device consists of a Smart Monitor 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. DyeVert Plus Disposable Kit The DyeVert™ Plus Contrast Reduction System consists of a Monitor and DyeVert Plus Disposable Kit. The system…
Read the full statement (301 words)
DyeVert™ Plus Contrast Reduction System
Smart Monitor
The device consists of a Smart Monitor 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.
DyeVert Plus Disposable Kit
The DyeVert™ Plus Contrast Reduction System consists of a Monitor and DyeVert Plus 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.
DyeVert™ Plus EZ Contrast Reduction System
Smart Monitor
The device consists of a Smart Monitor 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.
DyeVert Plus EZ Disposable Kit
The DyeVert™ Plus EZ Contrast Reduction System consists of a Monitor 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.
DyeTect™ Contrast Monitoring System
Smart Monitor
The device consists of a Smart Monitor 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.
DyeTect Contrast Monitoring Disposable Kit
The DyeTect Contrast Monitoring Disposable Kit consists of a Smart Syringe and Pressure Module to be used with the Monitor during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190102: DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, 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/K190102
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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