510(k) · Cleared
ClearedDyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring 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 Mar 8, 2017 as substantially equivalent to K161505 (Osprey Medical, Inc., 2016) and 1 other predicate after a 127-day review. Its family tree reaches back 10 generations to 1982. 5 later devices descend from it.
- Decided
- Mar 8, 2017
- Review
- 127 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K822536 (1982). 19 ancestors in all. 5 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK822536 MARK VMedrad, Inc. · 1982
- 6 generations between
- 3 generations backK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- 2 generations backK153141 DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016
- 1 generation backK161505 DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016
- This deviceK163054 DyeVert Plus Contrast Modulation/Monitoring System, Contrast…Osprey Medical, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK181936 DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK171698 Smart SyringeOsprey Medical, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK171217 DyeVert Plus Contrast Reduction System, DyeVert NG Contrast…Osprey Medical, Inc. · 2017
- 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 10 generations
- Root · 10 generations backK822536 MARK VMedrad, Inc. · 1982
- 9 generations backK963982 Acist Angiographic InjectorInvasatec · 1997
- 8 generations backK984058 Acist Injector System, Model CL100 HAcist Medical Systems · 1999
- 7 generations backK991103 Modification to Acist CL 100HAcist Medical Systems · 2000 · Recalled
- 6 generations backK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
- 5 generations backK140425 Contrast Modulation SystemOsprey Medical, Inc. · 2014
- 4 generations backK150485 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- 3 generations backK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- 2 generations backK153141 DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016
- 1 generation backK161505 DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016
- This deviceK163054 DyeVert Plus Contrast Modulation/Monitoring System, Contrast…Osprey Medical, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K181936DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018 · cites it directly2descendants
- K171698Smart SyringeOsprey Medical, Inc. · 2017 · cites it directly1descendant
- K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemOsprey Medical, Inc. · 2017 · cites it directly1descendant
- 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 |
|---|---|---|---|---|---|
| −10 | K822536 | MARK V | Medrad, Inc. | 1982 | — |
| −9 | K963982 | Acist Angiographic Injector | Invasatec | 1997 | — |
| −8 | K984058 | Acist Injector System, Model CL100 H | Acist Medical Systems | 1999 | — |
| −7 | K991103 | Modification to Acist CL 100H | Acist Medical Systems | 2000 | 3 |
| −6 | K131478 | Contrast Conservation System | Osprey Medical, Inc. | 2013 | — |
| −5 | K140425 | Contrast Modulation System | Osprey Medical, Inc. | 2014 | — |
| −4 | K150485 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| −3 | K151300 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| −2 | K153141 | DyeVert Contrast Modulation System | Osprey Medical, Inc. | 2016 | — |
| −1 | K161505 | DyeVert NG Contrast Modulation System | Osprey Medical, Inc. | 2016 | — |
| 0 (this device) | 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 | — |
| +1 | K171698 | Smart Syringe | Osprey Medical, Inc. | 2017 | — |
| +1 | K171217 | DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System | Osprey Medical, Inc. | 2017 | — |
| +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 |
|---|---|---|
| 2017 | 2 | 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 |
|---|---|---|---|
| * | K161505 | DyeVert NG Contrast Modulation SystemSummary page 5…II CFR Reference: 21 CFR § 870.1650 Product Code: DXT 510(k) number(s) K161505 Secondary Predicate Device: Trade Name/Proprietary Name: CMS™ Contrast Monitoring System Manufacturer:… | 2016 |
| * | K142081 | Contrast Monitoring System Display, Contrast Monitoring System SyringesSummary page 5…II CFR Reference: 21 CFR § 870.1650 Product Code: DXT 510(k) number(s) K142081 Comparison to the Predicate Device: The proposed devices are substantially equivalent to the previously cleared DyeVert Contrast… | 2014 |
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181936 | DyeVert PLUS EZ Contrast Reduction System | 2018 | 2 |
| K171698 | Smart Syringe | 2017 | 1 |
| K171217 | DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System | 2017 | 1 |
| K190102 | DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™… | 2019 | 0 |
| K183267 | DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System… | 2018 | 0 |
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 35 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K181936 (Osprey Medical, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K161505.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 or the Contrast monitoring Disposable Kit during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media. The DyeVert™ Plus Contrast Modulation/Monitoring System consists of a Display 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…
Read the full statement (119 words)
The device consists of a display to be used with the DyeVert Plus Disposable Kit or the Contrast monitoring Disposable Kit during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.
The DyeVert™ Plus Contrast Modulation/Monitoring System consists of a Display 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.
The device consists of a Smart Syringe and Pressure Module to be used with the Contrast Monitoring Display 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/K163054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163054: DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163054
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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