510(k) · Cleared
ClearedContrast Monitoring System Display, Contrast Monitoring System Syringes
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 Dec 12, 2014 as substantially equivalent to K093830 (Medline Industries, Inc., 2011) after a 134-day review. Its family tree reaches back 1 generation to 2011. 6 later devices descend from it.
- Decided
- Dec 12, 2014
- Review
- 134 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093830 (2011). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK093830 Medline Angiographic Control SyringeMedline Industries, Inc. · 2011
- This deviceK142081 Contrast Monitoring System Display, Contrast Monitoring System…Osprey Medical, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK163054 DyeVert Plus Contrast Modulation/Monitoring System, Contrast…Osprey Medical, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK181936 DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018
- Descendant · 2 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
- Descendant · 2 generations on · 0 of its ownK190102 DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast…Osprey Medical, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemOsprey Medical, Inc. · 2017 · cites it directly5descendants
- K181936DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018 · 2 generations on2descendants
- K171698Smart SyringeOsprey Medical, Inc. · 2017 · 2 generations on1descendant
- K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemOsprey Medical, Inc. · 2017 · 2 generations on1descendant
- K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™…Osprey Medical, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093830 | Medline Angiographic Control Syringe | Medline Industries, Inc. | 2011 | — |
| 0 (this device) | K142081 | Contrast Monitoring System Display, Contrast Monitoring System Syringes | Osprey Medical, Inc. | 2014 | — |
| +1 | K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System | Osprey Medical, Inc. | 2017 | — |
| +2 | K181936 | DyeVert PLUS EZ Contrast Reduction System | Osprey Medical, Inc. | 2018 | — |
| +2 | K171698 | Smart Syringe | Osprey Medical, Inc. | 2017 | — |
| +2 | K171217 | DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System | Osprey Medical, Inc. | 2017 | — |
| +2 | K190102 | DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System… | Osprey Medical, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K093830 | Medline Angiographic Control SyringeSummary page 5…edia. Predicate Device: The Contrast Monitoring System is substantially equivalent in intended use and method of operation to the Medline Angiographic Control Syringe (K093830). The Contrast Monitoring System is also similar to the ACIST Angiographic Injection System (K993774, K991103 and K000013) in tha… | 2011 |
| † | K993774 | Acist Angiographic Injection System, Model CL1OOH | 1999 |
| † | K991103 | Modification to Acist CL 100H | 2000 |
| † | K000013 | Acist Angiographic Injection System, Model R-2000 | 2000 |
| † | K875196 | Disposable Coronary Control Syringe 12CC | 1988 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System | 2017 | 5 |
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?
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 device consists of a manual syringe and display to be used during Angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.
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/K142081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142081: Contrast Monitoring System Display, Contrast Monitoring System Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142081
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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