510(k) Report

510(k) · Cleared

Cleared

DyeVert NG Contrast Modulation System

K161505510(k) SpecialCleared Aug 3, 201663-day reviewClass II21 CFR 870.1650

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Osprey Medical, Inc. · DXT Injector And Syringe, Angiographic

Cleared on Aug 3, 2016 as substantially equivalent to K153141 (Osprey Medical, Inc., 2016) after a 63-day review. Its family tree reaches back 9 generations to 1982. 6 later devices descend from it.

Decided
Aug 3, 2016
Review
63 days
Class
Class II
Product code
DXT
Recalls
None
Predicates
1

Its longest line of descent runs back 9 generations to K822536 (1982). 17 ancestors in all. 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2011: 1 other ancestor2005: 1 other ancestor2000: 2 other ancestors1999: 1 other ancestor1996: 1 other ancestor1991: 1 other ancestor2018: 2 descendants cleared2017: 3 descendants cleared2019: 1 descendant clearedReference device: K151300 · AVERT Contrast Modulation System · Osprey Medical, Inc. · 2015Reference device: K994253 · Vaclok Syringe · Merit Medical Systems, Inc. · 2000 · recalledK822536 · MARK V · Medrad, Inc. · 1982K963982 · Acist Angiographic Injector · Invasatec · 1997K984058 · Acist Injector System, Model CL100 H · Acist Medical Systems · 1999K991103 · Modification to Acist CL 100H · Acist Medical Systems · 2000 · recalledK131478 · Contrast Conservation System · Osprey Medical, Inc. · 2013K140425 · Contrast Modulation System · Osprey Medical, Inc. · 2014K150485 · AVERT Contrast Modulation System · Osprey Medical, Inc. · 2015×2: 2 generations cleared close together, K151300 (2015), K153141 (2016) 19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor5 generations back: 4 other ancestors6 generations back: 1 other ancestor7 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants K153141 · DyeVert Contrast Modulation System · Osprey Medical, Inc. · 2016K151300 · AVERT Contrast Modulation System · Osprey Medical, Inc. · 2015K150485 · AVERT Contrast Modulation System · Osprey Medical, Inc. · 2015K140425 · Contrast Modulation System · Osprey Medical, Inc. · 2014K131478 · Contrast Conservation System · Osprey Medical, Inc. · 2013K991103 · Modification to Acist CL 100H · Acist Medical Systems · 2000 · recalledK984058 · Acist Injector System, Model CL100 H · Acist Medical Systems · 1999K963982 · Acist Angiographic Injector · Invasatec · 1997K822536 · MARK V · Medrad, Inc. · 1982−50
  1. Root · 9 generations backK822536 MARK VMedrad, Inc. · 1982
  2. 5 generations between
  3. 3 generations backK150485 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
  4. 2 generations backK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
  5. 1 generation backK153141 DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016
  6. This deviceK161505 DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016
  7. Descendant · cites it directly · 5 of its ownK163054 DyeVert Plus Contrast Modulation/Monitoring System, Contrast…Osprey Medical, Inc. · 2017
  8. Descendant · 2 generations on · 2 of its ownK181936 DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018
  9. Descendant · 2 generations on · 1 of its ownK171698 Smart SyringeOsprey Medical, Inc. · 2017
  10. Descendant · cites it directly · 1 of its ownK171217 DyeVert Plus Contrast Reduction System, DyeVert NG Contrast…Osprey Medical, Inc. · 2017
  11. Descendant · 2 generations on · 0 of its ownK190102 DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast…Osprey Medical, Inc. · 2019
Show all 9 generations
  1. Root · 9 generations backK822536 MARK VMedrad, Inc. · 1982
  2. 8 generations backK963982 Acist Angiographic InjectorInvasatec · 1997
  3. 7 generations backK984058 Acist Injector System, Model CL100 HAcist Medical Systems · 1999
  4. 6 generations backK991103 Modification to Acist CL 100HAcist Medical Systems · 2000 · Recalled
  5. 5 generations backK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
  6. 4 generations backK140425 Contrast Modulation SystemOsprey Medical, Inc. · 2014
  7. 3 generations backK150485 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
  8. 2 generations backK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
  9. 1 generation backK153141 DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016
  10. This deviceK161505 DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. · 2016

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2017: 32018: 22019: 1
2017high 3 (2017) · low 0 (2020)2026

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 · cites it directly1descendant
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−9K822536MARK VMedrad, Inc.1982—
−8K963982Acist Angiographic InjectorInvasatec1997—
−7K984058Acist Injector System, Model CL100 HAcist Medical Systems1999—
−6K991103Modification to Acist CL 100HAcist Medical Systems20003
−5K131478Contrast Conservation SystemOsprey Medical, Inc.2013—
−4K140425Contrast Modulation SystemOsprey Medical, Inc.2014—
−3K150485AVERT Contrast Modulation SystemOsprey Medical, Inc.2015—
−2K151300AVERT Contrast Modulation SystemOsprey Medical, Inc.2015—
−1K153141DyeVert Contrast Modulation SystemOsprey Medical, Inc.2016—
0 (this device)K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc.2016—
+1K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemOsprey Medical, Inc.2017—
+2K181936DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc.2018—
+2K171698Smart SyringeOsprey Medical, Inc.2017—
+1K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemOsprey Medical, Inc.2017—
+2K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System…Osprey Medical, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199610
199910
200020
200510
201110
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201730
201820
201910
FIG. 1 — Lineage of K161505, 1982–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253048 High Pressure Syringe; Pressure Connecting…score 13.6 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K153141DyeVert Contrast Modulation System
Summary page 5
…r and Syringe, Angiographic Classification Registration: 21 CFR § 870.1650 Product Code: DXT 510(k) number(s) K153141 Reference Predicate Device(s): Trade Name/Proprietary Name: AVERT™ Contrast Modulation System Manufacturer:…
Osprey Medical, Inc.2016—
†K151300AVERT Contrast Modulation SystemOsprey Medical, Inc.2015—
†K994253Vaclok SyringeMerit Medical Systems, Inc.200011

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemOsprey Medical, Inc.20175
K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemOsprey Medical, Inc.20171
K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System…Osprey Medical, Inc.20180

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 34 years and passes through 4 companies; a new generation was cleared every 10 months on median.
  • 3 of the 17 ancestors have a recall of any class.
  • Of its descendants, K163054 (Osprey Medical, Inc., 2017) has gone furthest, with 5 descendants of its own.

How does its category compare?

All DXT devices

DXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · DXT

1in 2025

2007: 32008: 22009: 62010: 12011: 42013: 22014: 62015: 72016: 82017: 72018: 92019: 42020: 32021: 12023: 12024: 42025: 12026 (partial year): 7
2007high 9 (2018) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXT

138in 2024

2007: 182 days median2009: 137 days median2011: 69 days median2014: 144 days median2015: 153 days median2016: 172 days median2017: 183 days median2018: 93 days median2019: 96 days median2020: 154 days median2024: 138 days median2026 (partial year): 264 days median
2007high 264 (2026) · low 69 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXT

10in 2024

2007: 42008: 32009: 72010: 32011: 32012: 72015: 12018: 22020: 12021: 12023: 22024: 102026 (partial year): 6
2007high 10 (2024) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXT

97in 2025

2007: 1072008: 1682009: 1882010: 1242011: 1332012: 1352013: 1412014: 972015: 1352016: 1522017: 1282018: 1292019: 1212020: 932021: 1322022: 1112023: 1172024: 1182025: 97
2007high 188 (2009) · low 93 (2020)2025

MAUDE reports naming product code DXT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200731824107
20082—3168
200961377188
20101—3124
20114693133
20120—7135
20132—0141
20146144097
201571531135
201681720152
201771830128
20189932129
20194960121
20203154193
20211—1132
20220—0111
20231—2117
2024413810118
20251—097
202672646—

What is it indicated for?

The DyeVert™ NG Contrast Modulation System is to be used for the controlled infusion and contrast volume reduction 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 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.

More from Osprey Medical, Inc.

14 FDA decisions under this applicant name. See the company

  • K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast…Osprey Medical, Inc. · 2019
  • K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast…Osprey Medical, Inc. · 2018
  • K181936DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. · 2018
  • K171698Smart SyringeOsprey Medical, Inc. · 2017
  • K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemOsprey Medical, Inc. · 2017

Recent decisions in DXT

The DXT category page

  • K262043MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12)…Bayer Medical Care, Inc. · 2026
  • K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for…Fortis Biosolutions Company Limited · 2026
  • K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro…Acist Medical Systems, Inc. · 2026
  • K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single…Acist Medical Systems, Inc. · 2026
  • K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd. · 2026

https://510kreport.com/device/K161505 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161505: DyeVert NG 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/K161505

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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