510(k) · Cleared
ClearedPRESS DUO elite, PRESS DUO elite AG
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 Feb 7, 2018 as substantially equivalent to K963071 (Mallinckrodt Inc., Liebel-Flarsheim Business, 1997) and 3 other predicates after a 93-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Feb 7, 2018
- Review
- 93 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K934086 (1995). 17 ancestors in all, the oldest K860204 (1986). No later device cites it as a predicate yet.
- Root · 7 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 6 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- 5 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
- 4 generations backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- 3 generations backK052633 Dual Shot - Contrast Delivery SystemNemoto Kyorindo Co., Ltd. · 2005
- 2 generations backK062168 Contrast Delivery System - Dual Shot AlphaNemoto Kyorindo Co., Ltd. · 2006
- 1 generation backK133189 Dual Shot Alpha 7Nemoto Kyorindo Co., Ltd. · 2014
- This deviceK173450 PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −6 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| −5 | K023183 | Medrad Stellant CT Injector System | Medrad, Inc. | 2003 | 6 |
| −4 | K033881 | Medrad Stellant CT Injector System with Imaging System Interface Module | Medrad, Inc. | 2004 | 1 |
| −3 | K052633 | Dual Shot - Contrast Delivery System | Nemoto Kyorindo Co., Ltd. | 2005 | — |
| −2 | K062168 | Contrast Delivery System - Dual Shot Alpha | Nemoto Kyorindo Co., Ltd. | 2006 | — |
| −1 | K133189 | Dual Shot Alpha 7 | Nemoto Kyorindo Co., Ltd. | 2014 | — |
| 0 (this device) | K173450 | PRESS DUO elite, PRESS DUO elite AG | Nemoto Kyorindo Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963071 | Angiomat IllumenaSummary page 4…Angiography Contrast Media Delivery System Classification Name: Injector and Syringe, Angiographic Predicate Device(s): Angiomat Illumena Injector, K963071 (Primary predicate) Dual Shot alpha 7, K133189 (Secondary predicate)… | 1997 |
| * | K133189 | Dual Shot Alpha 7Summary page 4…ctor and Syringe, Angiographic Predicate Device(s): Angiomat Illumena Injector, K963071 (Primary predicate) Dual Shot alpha 7, K133189 (Secondary predicate) Rempress, K092896 (Secondary predicate) Med… | 2014 |
| * | K092896 | Rempress and Angiography Contrast Delivery System RempressSummary page 4…Illumena Injector, K963071 (Primary predicate) Dual Shot alpha 7, K133189 (Secondary predicate) Rempress, K092896 (Secondary predicate) Medrad Mark 7 Arterion Injection System, K132928 (Secondary predicate) In… | 2010 |
| * | K132928 | Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO SyringeSummary page 4…89 (Secondary predicate) Rempress, K092896 (Secondary predicate) Medrad Mark 7 Arterion Injection System, K132928 (Secondary predicate) Indications for Use / Intended Use: The PRESS DUO elite is intended to be used for injecting contrast med… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 8 of the 17 ancestors have a recall of any class.
- 2 other devices also cite its predicate K963071.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 PRESS DUO elite is intended to be used for injecting contrast media and common flushing solution into the vascular system in Angiographic and Computed Tomography (CT) procedures whereas the PRESS DUO elite AG is intended to be used for injecting contrast media and common flushing solution into the vascular system for Angiographic procedures only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173450: PRESS DUO elite, PRESS DUO elite AG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173450
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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