510(k) · Cleared
ClearedAVERT 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 Mar 26, 2015 as substantially equivalent to K140425 (Osprey Medical, Inc., 2014) after a 30-day review. Its family tree reaches back 6 generations to 1982. 10 later devices descend from it.
- Decided
- Mar 26, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K822536 (1982). 13 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK822536 MARK VMedrad, Inc. · 1982
- 5 generations backK963982 Acist Angiographic InjectorInvasatec · 1997
- 4 generations backK984058 Acist Injector System, Model CL100 HAcist Medical Systems · 1999
- 3 generations backK991103 Modification to Acist CL 100HAcist Medical Systems · 2000 · Recalled
- 2 generations backK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
- 1 generation backK140425 Contrast Modulation SystemOsprey Medical, Inc. · 2014
- This deviceK150485 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- Descendant · cites it directly · 8 of its ownK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK153141 DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016
- Descendant · 3 generations on · 6 of its ownK161505 DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016
- Descendant · 4 generations on · 5 of its ownK163054 DyeVert Plus Contrast Modulation/Monitoring System, Contrast…Osprey Medical, Inc. · 2017
- Descendant · 5 generations on · 2 of its ownK181936 DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K151300AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015 · cites it directly8descendants
- K153141DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016 · 2 generations on7descendants
- K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016 · 3 generations on6descendants
- K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemOsprey Medical, Inc. · 2017 · 4 generations on5descendants
- K181936DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K822536 | MARK V | Medrad, Inc. | 1982 | — |
| −5 | K963982 | Acist Angiographic Injector | Invasatec | 1997 | — |
| −4 | K984058 | Acist Injector System, Model CL100 H | Acist Medical Systems | 1999 | — |
| −3 | K991103 | Modification to Acist CL 100H | Acist Medical Systems | 2000 | 3 |
| −2 | K131478 | Contrast Conservation System | Osprey Medical, Inc. | 2013 | — |
| −1 | K140425 | Contrast Modulation System | Osprey Medical, Inc. | 2014 | — |
| 0 (this device) | K150485 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| +1 | K151300 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015 | — |
| +2 | K153141 | DyeVert Contrast Modulation System | Osprey Medical, Inc. | 2016 | — |
| +3 | K161505 | DyeVert NG Contrast Modulation System | Osprey Medical, Inc. | 2016 | — |
| +4 | K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System | Osprey Medical, Inc. | 2017 | — |
| +5 | K181936 | DyeVert PLUS EZ Contrast Reduction System | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 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? (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 |
|---|---|---|---|
| * | K140425 | Contrast Modulation SystemSummary page 5…r and Syringe, Angiographic Classification Registration: 21 CFR § 870.1650 Product Code: DXT 510(k) number(s) K140425 Comparison to the Predicate Device: The AVERT™ System is substantially equivalent and unchanged from the predicate AVERT™ Syste… | 2014 |
What descends from it? (10)
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 33 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K151300 (Osprey Medical, Inc., 2015) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K140425.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 AVERT™ Contrast Modulation System is intended to be used for the controlled infusion 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 300 or 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/K150485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150485: AVERT Contrast Modulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150485
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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