510(k) · Cleared
ClearedAngiomat 6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Group, Inc. · DXT Injector And Syringe, Angiographic
Cleared on May 2, 1986 after a 100-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 2, 1986
- Review
- 100 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK860204 Angiomat 6000Mallinckrodt Group, Inc. · 1986
- Descendant · cites it directly · 3 of its ownK963071 Angiomat IllumenaMallinckrodt Inc., Liebel-Flarsheim Business · 1997 · Recalled
- Descendant · cites it directly · 1 of its ownK092896 Rempress and Angiography Contrast Delivery System RempressNemoto Kyorindo Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK173450 PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK082212 Syringe with Handi-FilMallinckrodt Inc., Liebel-Flarsheim Business · 2009
Most influential descendants
Showing 4 of 4 · See all- K963071Angiomat IllumenaMallinckrodt Inc., Liebel-Flarsheim Business · 1997 · cites it directly3descendants
- 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 · 2 generations on0descendants
- K082212Syringe with Handi-FilMallinckrodt Inc., Liebel-Flarsheim Business · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860204 | Angiomat 6000 | Mallinckrodt Group, Inc. | 1986 | — |
| +1 | K963071 | Angiomat Illumena | Mallinckrodt Inc., Liebel-Flarsheim Business | 1997 | 2 |
| +1 | K092896 | Rempress and Angiography Contrast Delivery System Rempress | Nemoto Kyorindo Co., Ltd. | 2010 | — |
| +2 | K173450 | PRESS DUO elite, PRESS DUO elite AG | Nemoto Kyorindo Co., Ltd. | 2018 | — |
| +2 | K082212 | Syringe with Handi-Fil | Mallinckrodt Inc., Liebel-Flarsheim Business | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K963071 (Mallinckrodt Inc., Liebel-Flarsheim Business, 1997) has gone furthest, with 3 descendants 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 | — |
https://510kreport.com/device/K860204 · printed Nov 5, 2026
Cite this page
510(k) Report. “K860204: Angiomat 6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K860204
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026