510(k) Report

510(k) · Cleared

Recalled · 2012

Optistar MR Injector System

K984088510(k) TraditionalCleared Dec 6, 1999385-day reviewClass II21 CFR 870.1650Recalls 5

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

Mallinckrodt Inc., Liebel-Flarsheim Business · DXT Injector And Syringe, Angiographic

Cleared on Dec 6, 1999 as substantially equivalent to K935668 (Medrad, Inc., 1995) after a 385-day review. Its family tree reaches back 1 generation to 1995. 22 later devices descend from it. It has been recalled 5 times.

Decided
Dec 6, 1999
Review
385 days
Class
Class II
Product code
DXT
Recalls
5
Predicates
1

Its longest line of descent runs back 1 generation to K935668 (1995). 22 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2005: 1 descendant cleared2008: 2 descendants cleared2010: 1 descendant cleared2012: 1 descendant cleared2017: 3 descendants cleared2024: 2 descendants cleared2016: 3 descendants cleared2018: 2 descendants cleared2009: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared2026: 2 descendants clearedK935668 · Medrad Spectris MR Injector · Medrad, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 5 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants K935668 · Medrad Spectris MR Injector · Medrad, Inc. · 19950+5
  1. Root · 1 generation backK935668 Medrad Spectris MR InjectorMedrad, Inc. · 1995
  2. This deviceK984088 Optistar MR Injector SystemMallinckrodt Inc., Liebel-Flarsheim Business · 1999
  3. Descendant · cites it directly · 18 of its ownK051799 Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
  4. Descendant · 2 generations on · 15 of its ownK072696 Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008
  5. Descendant · 3 generations on · 8 of its ownK151960 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016
  6. Descendant · 4 generations on · 4 of its ownK192657 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2020
  7. Descendant · 5 generations on · 2 of its ownK211564 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2021

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2005: 12008: 22009: 12010: 12012: 12014: 12016: 32017: 32018: 22020: 22021: 12024: 22026: 2
2005high 3 (2016) · low 0 (2006)2026

Most influential descendants

Showing 5 of 22 · See all
  • K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005 · cites it directly18descendants
  • K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008 · 2 generations on15descendants
  • K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016 · 3 generations on8descendants
  • K192657Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2020 · 4 generations on4descendants
  • K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2021 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K935668Medrad Spectris MR InjectorMedrad, Inc.1995—
0 (this device)K984088Optistar MR Injector SystemMallinckrodt Inc., Liebel-Flarsheim Business1999—
+1K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.2005—
+2K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd.2008—
+3K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.2016—
+4K192657Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.2020—
+5K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200820
200910
201010
201210
201410
201630
201730
201820
202020
202110
202420
202620
FIG. 1 — Lineage of K984088, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K935668Medrad Spectris MR Injector
Summary page 1
…Optistar MR Injector System Common Name: Injector System Classification Name: Injector and Syringe, Angiographic Predicate Device: Medrad Spectris MR Injection System (K935668) Intended Use: The Optistar MR Injector System is intended for injecting MR contrast agents and flushing solutions for the purp…
Medrad, Inc.1995—

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.200518
K140469MR Syringe Dual PackCoeur, Inc.20140
K120375Med-RX Patient Delivery SetBenlan, Inc.20120
K091734Sonic Shot GXNemoto Kyorindo Co., Ltd.20100
K073592Optistar Elite Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business20080

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 10, 2012Not classifiedZ-1121-2012Packaging process controlThe machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.
Feb 10, 2012Not classifiedZ-1120-2012Packaging process controlThe machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.
Feb 10, 2012Not classifiedZ-1122-2012Packaging process controlThe machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.
Feb 10, 2012Not classifiedZ-1118-2012Packaging process controlThe machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.
Feb 10, 2012Not classifiedZ-1119-2012Packaging process controlThe machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K051799 (Coeur, Inc., 2005) has gone furthest, with 18 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—

What is it indicated for?

The Optistar MR is designed to inject MR contrast agents and flushing solutions for the purpose of enhancing diagnostic imaging of humans.

Contraindications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts. Not to be used in a magnetic field greater than 1.5 Tesla.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Mallinckrodt Inc., Liebel-Flarsheim…

8 FDA decisions under this applicant name. See the company

  • K082212Syringe with Handi-FilMallinckrodt Inc., Liebel-Flarsheim Business · 2009
  • K073592Optistar Elite Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business · 2008
  • K063503Optivantage DH Injector System with Enhanced CommunicationMallinckrodt Inc., Liebel-Flarsheim Business · 20071 recall
  • K042744Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business · 20041 recall
  • K031339OptibolusMallinckrodt Inc., Liebel-Flarsheim Business · 20031 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/K984088 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984088: Optistar MR Injector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984088

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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