510(k) · Cleared
ClearedRempress and Angiography Contrast Delivery System Rempress
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 Oct 29, 2010 as substantially equivalent to K963071 (Mallinckrodt Inc., Liebel-Flarsheim Business, 1997) and 1 other predicate after a 403-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- Oct 29, 2010
- Review
- 403 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K860204 (1986). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK860204 Angiomat 6000Mallinckrodt Group, Inc. · 1986
- 1 generation backK963071 Angiomat IllumenaMallinckrodt Inc., Liebel-Flarsheim Business · 1997 · Recalled
- This deviceK092896 Rempress and Angiography Contrast Delivery System RempressNemoto Kyorindo Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK173450 PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173450PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K860204 | Angiomat 6000 | Mallinckrodt Group, Inc. | 1986 | — |
| −1 | K963071 | Angiomat Illumena | Mallinckrodt Inc., Liebel-Flarsheim Business | 1997 | 2 |
| 0 (this device) | K092896 | Rempress and Angiography Contrast Delivery System Rempress | Nemoto Kyorindo Co., Ltd. | 2010 | — |
| +1 | 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 |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 1…Injector System Classification Name: Injector and Syringe, Angiographic Predicate Device(s): Angiomat Illumena Injector, K963071 Angiomat 6000 Injector, K860204 Intended Use:… | 1997 |
| * | K860204 | Angiomat 6000Summary page 1…Injector and Syringe, Angiographic Predicate Device(s): Angiomat Illumena Injector, K963071 Angiomat 6000 Injector, K860204 Intended Use: injection system intended for the administration Th… | 1986 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173450 | PRESS DUO elite, PRESS DUO elite AG | 2018 | 0 |
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 24 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K173450 (Nemoto Kyorindo Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 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. 2010, 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 contrast delivery system REMPRESS is an intravascular injection system intended for the administration of contrast media or normal saline used in conjunction with angiographic imaging procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092896 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092896: Rempress and Angiography Contrast Delivery System Rempress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092896
Report an extraction error
Are you the manufacturer?
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