510(k) Report

510(k) · Cleared

Recalled · 2008

Optibolus

K031339510(k) SpecialCleared Jul 11, 200374-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

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

Cleared on Jul 11, 2003 as substantially equivalent to K912944 (Mallinckrodt Group, Inc., 1992) after a 74-day review. Its family tree reaches back 1 generation to 1992. 12 later devices descend from it. It has been recalled once.

Decided
Jul 11, 2003
Review
74 days
Class
Class II
Product code
DXT
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K912944 (1992). 12 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2007: 2 descendants cleared2016: 1 descendant cleared2014: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2018: 2 descendants cleared2021: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant clearedK912944 · CT 8000 Digital Injection System · Mallinckrodt Group, Inc. · 1992 · recalled1990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 2 descendants7 generations forward: 1 descendant K912944 · CT 8000 Digital Injection System · Mallinckrodt Group, Inc. · 1992 · recalled0+5
  1. Root · 1 generation backK912944 CT 8000 Digital Injection SystemMallinckrodt Group, Inc. · 1992 · Recalled
  2. This deviceK031339 OptibolusMallinckrodt Inc., Liebel-Flarsheim Business · 2003
  3. Descendant · cites it directly · 11 of its ownK042744 Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business · 2004 · Recalled
  4. Descendant · 2 generations on · 7 of its ownK072886 Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007
  5. Descendant · 3 generations on · 5 of its ownK082905 Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc. · 2009 · Recalled
  6. Descendant · 4 generations on · 4 of its ownK173773 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
  7. Descendant · 5 generations on · 3 of its ownK182273 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2004: 12007: 22008: 12009: 12014: 12016: 12018: 22019: 12021: 12025: 1
2004high 2 (2007) · low 0 (2005)2026

Most influential descendants

Showing 5 of 12 · See all
  • K042744Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business · 2004 · cites it directly11descendants
  • K072886Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007 · 2 generations on7descendants
  • K082905Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc. · 2009 · 3 generations on5descendants
  • K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc. · 2018 · 4 generations on4descendants
  • K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc. · 2018 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K912944CT 8000 Digital Injection SystemMallinckrodt Group, Inc.19921
0 (this device)K031339OptibolusMallinckrodt Inc., Liebel-Flarsheim Business2003—
+1K042744Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business20041
+2K072886Medrad Stellant CT Injector System with P3TMedrad, Inc.2007—
+3K082905Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc.20092
+4K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD…Bayer Medical Care, Inc.20181
+5K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD…Bayer Medical Care, Inc.20181

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200720
200810
200910
201410
201610
201820
201910
202110
202510
FIG. 1 — Lineage of K031339, 1992–2025Source: 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
*K912944CT 8000 Digital Injection System
Summary page 2
…arket. 8. Substantial Equivalence The Predicate injector to the CT9000ADV / OptiBolus Injection System is the CT 8000 Digital Injection System, 510(k) number K912944 currently marketed under the name CT 9000ADV. The predicate device (CT 8000 Digital Injection System) is designed to m…
Mallinckrodt Group, Inc.19921

Also cleared against K912944: 5 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K042744Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business200411

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 14, 2008Not classifiedZ-1828-2008Device DesignThe tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K042744 (Mallinckrodt Inc., Liebel-Flarsheim Business, 2004) has gone furthest, with 11 descendants of its own.
  • 5 other devices also cite its predicate K912944.

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 CT9000ADV is designed to inject a radiopaque contrast media into a patient's vascular system, which enhances diagnostic images obtained with computed tomography (Le. "CT"). Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume and timing.

Indications for use as stated in the FDA summary.

Also cleared against K912944

5 other devices cite the same predicate.

  • K070798Adapters for CT, Angiographic, and/or Mri Power InjectorsCoeur, Inc. · 2007
  • K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
  • K022116Elph Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business · 2002
  • K9838263S Injector-CT Contrast Delivery SystemUnimachs Corp. · 2000
  • K963071Angiomat IllumenaMallinckrodt Inc., Liebel-Flarsheim Business · 19972 recalls

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
  • K022116Elph Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business · 2002

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/K031339 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031339: Optibolus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031339

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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