510(k) · Cleared
ClearedCoeur 130 ML Angiographic Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coeur Laboratories, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Oct 8, 1997 after a 152-day review. The FDA summary names its predicate without a number. 20 later devices descend from it.
- Decided
- Oct 8, 1997
- Review
- 152 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 2 citing it directly.
- This deviceK971712 Coeur 130 ML Angiographic SyringeCoeur Laboratories, Inc. · 1997
- Descendant · cites it directly · 18 of its ownK051799 Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
- Descendant · 2 generations on · 15 of its ownK072696 Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008
- Descendant · 3 generations on · 8 of its ownK151960 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016
- Descendant · 4 generations on · 4 of its ownK192657 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2020
- Descendant · 5 generations on · 2 of its ownK211564 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2021
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005 · cites it directly18descendants
- K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008 · 2 generations on15descendants
- K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016 · 3 generations on8descendants
- K192657Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2020 · 4 generations on4descendants
- K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971712 | Coeur 130 ML Angiographic Syringe | Coeur Laboratories, Inc. | 1997 | — |
| +1 | K051799 | Disposable CT/MR Syringes for Nemoto Injectors | Coeur, Inc. | 2005 | — |
| +2 | K072696 | Ant Angiographic Syringes, Model (S)… | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2008 | — |
| +3 | K151960 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Baoan Medical Supplies Co., Ltd. | 2016 | — |
| +4 | K192657 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | 2020 | — |
| +5 | K211564 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | Coeur 130ML Angiographic Syringe Named without a submission number |
What descends from it? (20)
See all 202 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, K051799 (Coeur, Inc., 2005) has gone furthest, with 18 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 | — |
What is it indicated for?
For use with Medrad Mark II, III,and IV Angiographic Imjectors.
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/K971712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971712: Coeur 130 ML Angiographic Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971712
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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