510(k) Report

510(k) · Cleared

Recalled · 2008

CT 8000 Digital Injection System

K912944510(k) TraditionalCleared Feb 4, 1992214-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 Group, Inc. · DXT Injector And Syringe, Angiographic

Cleared on Feb 4, 1992 after a 214-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 39 later devices descend from it. It has been recalled once.

Decided
Feb 4, 1992
Review
214 days
Class
Class II
Product code
DXT
Recalls
1
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2005: 1 descendant cleared2000: 1 descendant cleared2007: 3 descendants cleared2003: 1 descendant cleared1997: 1 descendant cleared2004: 1 descendant cleared2014: 2 descendants cleared2008: 2 descendants cleared2017: 3 descendants cleared2024: 2 descendants cleared2010: 1 descendant cleared2009: 3 descendants cleared2018: 5 descendants cleared2016: 4 descendants cleared2020: 2 descendants cleared2021: 2 descendants cleared2026: 2 descendants cleared2019: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK912944 CT 8000 Digital Injection SystemMallinckrodt Group, Inc. · 1992
  2. Descendant · cites it directly · 19 of its ownK983826 3S Injector-CT Contrast Delivery SystemUnimachs Corp. · 2000
  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 · cites it directly · 12 of its ownK031339 OptibolusMallinckrodt Inc., Liebel-Flarsheim Business · 2003 · Recalled
  6. Descendant · 2 generations on · 11 of its ownK042744 Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business · 2004 · Recalled

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

1997: 12000: 12002: 12003: 12004: 12005: 12007: 32008: 22009: 32010: 12014: 22016: 42017: 32018: 52019: 12020: 22021: 22024: 22025: 12026: 2
1997high 5 (2018) · low 0 (1998)2026

Most influential descendants

Showing 5 of 39 · See all
  • K9838263S Injector-CT Contrast Delivery SystemUnimachs Corp. · 2000 · cites it directly19descendants
  • 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
  • K031339OptibolusMallinckrodt Inc., Liebel-Flarsheim Business · 2003 · cites it directly12descendants
  • K042744Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business · 2004 · 2 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912944CT 8000 Digital Injection SystemMallinckrodt Group, Inc.1992—
+1K9838263S Injector-CT Contrast Delivery SystemUnimachs Corp.2000—
+1K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.2005—
+2K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd.2008—
+1K031339OptibolusMallinckrodt Inc., Liebel-Flarsheim Business20031
+2K042744Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business20041

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200210
200310
200410
200510
200730
200820
200930
201010
201420
201640
201730
201850
201910
202020
202120
202420
202510
202620
FIG. 1 — Lineage of K912944, 1992–2026Source: 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
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K9838263S Injector-CT Contrast Delivery SystemUnimachs Corp.200019
K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.200518
K031339OptibolusMallinckrodt Inc., Liebel-Flarsheim Business200312
K963071Angiomat IllumenaMallinckrodt Inc., Liebel-Flarsheim Business19973
K070798Adapters for CT, Angiographic, and/or Mri Power InjectorsCoeur, Inc.20072
K022116Elph Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business20020

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?

  • Of its descendants, K983826 (Unimachs Corp., 2000) has gone furthest, with 19 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 Mallinckrodt Group, Inc.

27 FDA decisions under this applicant name. See the company

  • K945053LF CT Hig Pressure CathetersMallinckrodt Group, Inc. · 1995
  • K945140Uro-FloMallinckrodt Group, Inc. · 1995
  • K943581Hydradjust IV Urological TableMallinckrodt Group, Inc. · 19953 recalls
  • K943122Surgical DrapesMallinckrodt Group, Inc. · 1994
  • K934664HydragownMallinckrodt Group, Inc. · 1994

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/K912944 · printed Nov 4, 2026

Cite this page

510(k) Report. “K912944: CT 8000 Digital Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K912944

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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