510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Medrad Mark V-Plus Injector

K903390510(k) TraditionalCleared Sep 26, 199061-day reviewClass II21 CFR 870.1650Recalls 1

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

Medrad, Inc. · DXT Injector And Syringe, Angiographic

Cleared on Sep 26, 1990 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled once.

Decided
Sep 26, 1990
Review
61 days
Class
Class II
Product code
DXT
Recalls
1
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2009: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant cleared1990200020102020
  1. This deviceK903390 Medrad Mark V-Plus InjectorMedrad, Inc. · 1990
  2. Descendant · cites it directly · 4 of its ownK112086 Medrad Mark 7 Arterion (Pedestal System / Table Mount System)…Medrad, Inc. · 2011 · Recalled
  3. Descendant · 2 generations on · 3 of its ownK113133 Medrad Mark 7 Arterion (Pedestal System), (Table Mount System)…Medrad, Inc. · 2011
  4. Descendant · 2 generations on · 2 of its ownK132928 Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO SyringeMedrad, Inc. / Bayer Medical Care, Inc. · 2014 · Recalled
  5. Descendant · 3 generations on · 0 of its ownK193028 MEDRAD Mark 7 Arterion Injection SystemBayer Medical Care, Inc. · 2019
  6. Descendant · 3 generations on · 0 of its ownK173450 PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009: 12011: 22014: 12018: 12019: 1
2009high 2 (2011) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all
  • K112086Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion…Medrad, Inc. · 2011 · cites it directly4descendants
  • K113133Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion…Medrad, Inc. · 2011 · 2 generations on3descendants
  • K132928Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO SyringeMedrad, Inc. / Bayer Medical Care, Inc. · 2014 · 2 generations on2descendants
  • K193028MEDRAD Mark 7 Arterion Injection SystemBayer Medical Care, Inc. · 2019 · 3 generations on0descendants
  • K173450PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903390Medrad Mark V-Plus InjectorMedrad, Inc.1990—
+1K112086Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7…Medrad, Inc.20111
+2K113133Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7…Medrad, Inc.2011—
+2K132928Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO SyringeMedrad, Inc. / Bayer Medical Care, Inc.20142
+3K193028MEDRAD Mark 7 Arterion Injection SystemBayer Medical Care, Inc.2019—
+3K173450PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201120
201410
201810
201910
FIG. 1 — Lineage of K903390, 1990–2019Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K112086Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion…Medrad, Inc.20114
K090621Flowcardia Flowmater Injector, Model Inj 100Flowcardia, Inc.20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 14, 2018Class IIZ-0745-2019Device DesignIf the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K112086 (Medrad, Inc., 2011) has gone furthest, with 4 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.

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—

More from Medrad, Inc.

105 FDA decisions under this applicant name. See the company

  • K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc. · 20141 recall
  • K130381Angiojet Ultra Power Pulse KitMedrad, Inc. · 2013
  • K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System; Jetstream SC 1.6 SystemMedrad, Inc. · 2013
  • K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 SystemMedrad, Inc. · 2012
  • K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc. · 20121 recall

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/K903390 · printed Nov 4, 2026

Cite this page

510(k) Report. “K903390: Medrad Mark V-Plus Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903390

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026