510(k) Report

510(k) · Cleared

Cleared

3S Injector-CT Contrast Delivery System

K983826510(k) TraditionalCleared Mar 23, 2000511-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

Unimachs Corp. · DXT Injector And Syringe, Angiographic

Cleared on Mar 23, 2000 as substantially equivalent to K880493 (Medrad, Inc., 1988) and 3 other predicates after a 511-day review. Its family tree reaches back 1 generation to 1987. 19 later devices descend from it.

Decided
Mar 23, 2000
Review
511 days
Class
Class II
Product code
DXT
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K864227 (1987). 4 ancestors in all. 19 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor1992: 1 other ancestor1988: 1 other ancestor2005: 1 descendant cleared2014: 1 descendant cleared2008: 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 clearedK864227 · Percupump (TM) · E-Z-Em, Inc. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 5 descendants4 generations forward: 5 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants K864227 · Percupump (TM) · E-Z-Em, Inc. · 19870+5
  1. Root · 1 generation backK864227 Percupump (TM)E-Z-Em, Inc. · 1987
  2. This deviceK983826 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 · 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 19 descendants. See all descendants

Descendants cleared per year

2005: 12008: 12009: 12014: 12016: 32017: 32018: 22020: 22021: 12024: 22026: 2
2005high 3 (2016) · low 0 (2006)2026

Most influential descendants

Showing 5 of 19 · 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
−1K864227Percupump (TM)E-Z-Em, Inc.1987—
0 (this device)K9838263S 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—
+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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199210
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
200910
201410
201630
201730
201820
202020
202110
202420
202620
FIG. 1 — Lineage of K983826, 1987–2026Source: 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), 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? (4)

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
*K880493Medrad Microprocessor CT Injection System
Summary page 1
…d and indicated for use with radiopaque contrast media and CT imaging systems currently on the market. Below is a listing of equivalent predicate products: e Medrad MCT (K880493) and MCT Plus (K924116) manufactured by Medrad e CT 9000 Injector (K912944) manufactured by Liebel-Flarsheim Co. e PercuPump 1A…
Medrad, Inc.1988—
*K924116Medrad MCT, MCT Plus Injector/Medrad Front Load
Summary page 1
…with radiopaque contrast media and CT imaging systems currently on the market. Below is a listing of equivalent predicate products: e Medrad MCT (K880493) and MCT Plus (K924116) manufactured by Medrad e CT 9000 Injector (K912944) manufactured by Liebel-Flarsheim Co. e PercuPump 1A (K864227) manufactured…
Medrad, Inc.1993—
*K912944CT 8000 Digital Injection System
Summary page 1
…currently on the market. Below is a listing of equivalent predicate products: e Medrad MCT (K880493) and MCT Plus (K924116) manufactured by Medrad e CT 9000 Injector (K912944) manufactured by Liebel-Flarsheim Co. e PercuPump 1A (K864227) manufactured by E-Z-EM Inc. Description of Device: The Nemoto 3S…
Mallinckrodt Group, Inc.19921
*K864227Percupump (TM)
Summary page 1
…dicate products: e Medrad MCT (K880493) and MCT Plus (K924116) manufactured by Medrad e CT 9000 Injector (K912944) manufactured by Liebel-Flarsheim Co. e PercuPump 1A (K864227) manufactured by E-Z-EM Inc. Description of Device: The Nemoto 3S Injector- CT is an auto injector system developed to meet the…
E-Z-Em, Inc.1987—

Also cleared against K880493: 1 other device →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.200518

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?

  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K051799 (Coeur, Inc., 2005) has gone furthest, with 18 descendants of its own.
  • 1 other device also cites its predicate K880493.

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 3S INJECTOR - CT is intended for the administration of contrast media into patients for diagnostic x-ray studies.

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

Also cleared against K880493

1 other device cites the same predicate.

  • K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005

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/K983826 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983826: 3S Injector-CT Contrast Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983826

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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