510(k) Report

510(k) · Cleared

Cleared

Contrast Conservation System

K131478510(k) TraditionalCleared Aug 15, 201385-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 15, 2013 as substantially equivalent to K993774 (Acist Medical Systems, 1999) and 4 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1982. 13 later devices descend from it.

Decided
Aug 15, 2013
Review
85 days
Class
Class II
Product code
DXT
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K822536 (1982). 11 ancestors in all. 13 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2005: 1 other ancestor2000: 2 other ancestors1999: 1 other ancestor1996: 1 other ancestor1991: 1 other ancestor2014: 1 descendant cleared2015: 4 descendants cleared2016: 2 descendants cleared2018: 2 descendants cleared2017: 3 descendants cleared2019: 1 descendant clearedK822536 · 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 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 3 descendants6 generations forward: 3 descendants K991103 · 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. · 19820+5
  1. Root · 4 generations backK822536 MARK VMedrad, Inc. · 1982
  2. 3 generations backK963982 Acist Angiographic InjectorInvasatec · 1997
  3. 2 generations backK984058 Acist Injector System, Model CL100 HAcist Medical Systems · 1999
  4. 1 generation backK991103 Modification to Acist CL 100HAcist Medical Systems · 2000 · Recalled
  5. This deviceK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
  6. Descendant · cites it directly · 12 of its ownK140425 Contrast Modulation SystemOsprey Medical, Inc. · 2014
  7. Descendant · 2 generations on · 10 of its ownK150485 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
  8. Descendant · 2 generations on · 8 of its ownK151300 AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015
  9. Descendant · 2 generations on · 8 of its ownK151746 Dyevert Contrast Modulation SystemOsprey Medical, Inc. · 2015
  10. Descendant · 3 generations on · 7 of its ownK153141 DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2014: 12015: 42016: 22017: 32018: 22019: 1
2014high 4 (2015) · low 0 (2020)2026

Most influential descendants

Showing 5 of 13 · See all
  • K140425Contrast Modulation SystemOsprey Medical, Inc. · 2014 · cites it directly12descendants
  • K150485AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015 · 2 generations on10descendants
  • K151300AVERT Contrast Modulation SystemOsprey Medical, Inc. · 2015 · 2 generations on8descendants
  • K151746Dyevert Contrast Modulation SystemOsprey Medical, Inc. · 2015 · 2 generations on8descendants
  • K153141DyeVert Contrast Modulation SystemOsprey Medical, Inc. · 2016 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K822536MARK VMedrad, Inc.1982—
−3K963982Acist Angiographic InjectorInvasatec1997—
−2K984058Acist Injector System, Model CL100 HAcist Medical Systems1999—
−1K991103Modification to Acist CL 100HAcist Medical Systems20003
0 (this device)K131478Contrast Conservation SystemOsprey Medical, Inc.2013—
+1K140425Contrast Modulation SystemOsprey Medical, Inc.2014—
+2K150485AVERT Contrast Modulation SystemOsprey Medical, Inc.2015—
+2K151300AVERT Contrast Modulation SystemOsprey Medical, Inc.2015—
+2K151746Dyevert Contrast Modulation SystemOsprey Medical, Inc.2015—
+3K153141DyeVert Contrast Modulation SystemOsprey Medical, Inc.2016—

Other ancestors by year cleared

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201540
201620
201730
201820
201910
FIG. 1 — Lineage of K131478, 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? (5)

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
*K993774Acist Angiographic Injection System, Model CL1OOH
Summary page 1
…edicate devices: Device Reference 510(k) Number Indication for Use Acist Angiographic Injection System K993774, K(991103, .. intended to be used for K000013, and K(052744…
Acist Medical Systems1999—
*K991103Modification to Acist CL 100H
Summary page 1
…ices: Device Reference 510(k) Number Indication for Use Acist Angiographic Injection System K993774, K(991103, .. intended to be used for K000013, and K(052744 the c…
Acist Medical Systems20003
*K000013Acist Angiographic Injection System, Model R-2000
Summary page 1
…for Use Acist Angiographic Injection System K993774, K(991103, .. intended to be used for K000013, and K(052744 the controlled infusion of…
Acist Medical Systems2000—
*K052744C2000 Automated Manifold Kit
Summary page 1
…Angiographic Injection System K993774, K(991103, .. intended to be used for K000013, and K(052744 the controlled infusion of radiopaqu…
Acist Medical Systems, Inc.20051
*K093830Medline Angiographic Control Syringe
Summary page 1
…media forangogrphi prcedures Medline Angiographic Control Syringe K093830 An angiographic syringe is a…
Medline Industries, Inc.2011—

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140425Contrast Modulation SystemOsprey Medical, Inc.201412

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 31 years and passes through 4 companies; a new generation was cleared every 13.2 years on median.
  • 3 of the 11 ancestors have a recall of any class.
  • Of its descendants, K140425 (Osprey Medical, Inc., 2014) has gone furthest, with 12 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. 2013, 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 Osprey Medical AVERT Contrast Modulation System is intended to be used for the

controlled infusion of radiopaque lodixanol 270 mg/mI contrast media for angiographic

procedures.

Indications for use as stated in the FDA summary.

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/K131478 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131478: Contrast Conservation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131478

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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