510(k) · Cleared
Recalled · 2011Angiomat Illumena
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Inc., Liebel-Flarsheim Business · DXT Injector And Syringe, Angiographic
Cleared on Sep 23, 1997 as substantially equivalent to K860204 (Mallinckrodt Group, Inc., 1986) and 1 other predicate after a 412-day review. Its family tree reaches back 1 generation to 1986. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 23, 1997
- Review
- 412 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K860204 (1986). 2 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK860204 Angiomat 6000Mallinckrodt Group, Inc. · 1986
- This deviceK963071 Angiomat IllumenaMallinckrodt Inc., Liebel-Flarsheim Business · 1997
- Descendant · cites it directly · 1 of its ownK092896 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
- Descendant · cites it directly · 0 of its ownK082212 Syringe with Handi-FilMallinckrodt Inc., Liebel-Flarsheim Business · 2009
Most influential descendants
Showing 3 of 3 · See all- K092896Rempress and Angiography Contrast Delivery System RempressNemoto Kyorindo Co., Ltd. · 2010 · cites it directly1descendant
- K173450PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018 · cites it directly0descendants
- K082212Syringe with Handi-FilMallinckrodt Inc., Liebel-Flarsheim Business · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860204 | Angiomat 6000 | Mallinckrodt Group, Inc. | 1986 | — |
| 0 (this device) | K963071 | Angiomat Illumena | Mallinckrodt Inc., Liebel-Flarsheim Business | 1997 | — |
| +1 | 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 | — |
| +1 | K082212 | Syringe with Handi-Fil | Mallinckrodt Inc., Liebel-Flarsheim Business | 2009 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K860204 | Angiomat 6000Summary page 1…on Name: Cardiovascular Diagnostic Device per CFR 870.1650 Common/Usual Name: Proprictary Name: Predicate Devices: Injector System Angiomat Illumena Angiomat 6000 (K860204) CI 8000/9000 Injector (K912944) Device Description: The Angiomat THlumena is designed to inject a radiopaque conlrast medium… | 1986 |
| * | K912944 | CT 8000 Digital Injection SystemSummary page 1…ic Device per CFR 870.1650 Common/Usual Name: Proprictary Name: Predicate Devices: Injector System Angiomat Illumena Angiomat 6000 (K860204) CI 8000/9000 Injector (K912944) Device Description: The Angiomat THlumena is designed to inject a radiopaque conlrast medium into the vascular system lor Angi… | 1992 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2011 | Not classified | Z-2859-2011 | Other | Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101. |
| Aug 24, 2007 | Not classified | Z-0056-2008 | Device Design | Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console and the unit's auxiliary consoles… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.
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/K963071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963071: Angiomat Illumena.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963071
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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