510(k) · Cleared
ClearedContrast Delivery System - Dual Shot Alpha
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nemoto Kyorindo Co., Ltd. · DXT Injector And Syringe, Angiographic
Cleared on Aug 18, 2006 as substantially equivalent to K052633 (Nemoto Kyorindo Co., Ltd., 2005) after an 18-day review. Its family tree reaches back 5 generations to 1995. 2 later devices descend from it.
- Decided
- Aug 18, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K934086 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 4 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- 3 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
- 2 generations backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- 1 generation backK052633 Dual Shot - Contrast Delivery SystemNemoto Kyorindo Co., Ltd. · 2005
- This deviceK062168 Contrast Delivery System - Dual Shot AlphaNemoto Kyorindo Co., Ltd. · 2006
- Descendant · cites it directly · 1 of its ownK133189 Dual Shot Alpha 7Nemoto Kyorindo Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK173450 PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −4 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| −3 | K023183 | Medrad Stellant CT Injector System | Medrad, Inc. | 2003 | 6 |
| −2 | K033881 | Medrad Stellant CT Injector System with Imaging System Interface Module | Medrad, Inc. | 2004 | 1 |
| −1 | K052633 | Dual Shot - Contrast Delivery System | Nemoto Kyorindo Co., Ltd. | 2005 | — |
| 0 (this device) | K062168 | Contrast Delivery System - Dual Shot Alpha | Nemoto Kyorindo Co., Ltd. | 2006 | — |
| +1 | K133189 | Dual Shot Alpha 7 | Nemoto Kyorindo Co., Ltd. | 2014 | — |
| +2 | K173450 | PRESS DUO elite, PRESS DUO elite AG | Nemoto Kyorindo Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
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 K253048 High Pressure Syringe; Pressure Connecting…score 13.6 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052633 | Dual Shot - Contrast Delivery System Our reading of the summary gave K056233, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “DUAL SHOT - CONTRAST DELIVERY SYSTEM”. | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133189 | Dual Shot Alpha 7 | 2014 | 1 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K133189 (Nemoto Kyorindo Co., Ltd., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXT
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXT
10in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXT
97in 2025
MAUDE reports naming product code DXT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 182 | 4 | 107 |
| 2008 | 2 | — | 3 | 168 |
| 2009 | 6 | 137 | 7 | 188 |
| 2010 | 1 | — | 3 | 124 |
| 2011 | 4 | 69 | 3 | 133 |
| 2012 | 0 | — | 7 | 135 |
| 2013 | 2 | — | 0 | 141 |
| 2014 | 6 | 144 | 0 | 97 |
| 2015 | 7 | 153 | 1 | 135 |
| 2016 | 8 | 172 | 0 | 152 |
| 2017 | 7 | 183 | 0 | 128 |
| 2018 | 9 | 93 | 2 | 129 |
| 2019 | 4 | 96 | 0 | 121 |
| 2020 | 3 | 154 | 1 | 93 |
| 2021 | 1 | — | 1 | 132 |
| 2022 | 0 | — | 0 | 111 |
| 2023 | 1 | — | 2 | 117 |
| 2024 | 4 | 138 | 10 | 118 |
| 2025 | 1 | — | 0 | 97 |
| 2026 | 7 | 264 | 6 | — |
What is it indicated for?
The Contrast Delivery System - Dual Shot Alpha is an intravascular injection system intended for the administration of ionic and non-ionic contrast media and saline used in conjunction with computed X-Ray tomography (CT).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062168: Contrast Delivery System - Dual Shot Alpha.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062168
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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