510(k) · Cleared
ClearedCoeur Front Load Injector Retrofit Kit (C859-0002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coeur Laboratories, Inc. · DTX Gas Control Unit, Cardiopulmonary Bypass
Cleared on Mar 28, 1997 after an 88-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.
- Decided
- Mar 28, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- DTX
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 2 citing it directly.
- This deviceK965214 Coeur Front Load Injector Retrofit Kit (C859-0002)Coeur 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 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · 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) | K965214 | Coeur Front Load Injector Retrofit Kit (C859-0002) | 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 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 2 | 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 DTX? 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 DTX device
- #1 K202733 Quantum Ventilation Modulescore 5.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 Front Load Injector Turret Named without a submission number | |
| * | — | Coeur Front Load Syringe Named without a submission number | |
| * | — | Medrad MCT and MCT Plus Injector with Front Load Syringe Named without a submission number |
What descends from it? (21)
See all 212 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 DTX devicesDTX Gas Control Unit, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTX
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DTX
Too few DTX 510(k)s in any year since 2007 to give a median.
Recalls per year · DTX
No recall names DTX since 2007.
Adverse event reports per year · DTX
127in 2025
MAUDE reports naming product code DTX, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 0 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 36 |
| 2017 | 0 | — | 0 | 41 |
| 2018 | 1 | — | 0 | 48 |
| 2019 | 0 | — | 0 | 53 |
| 2020 | 1 | — | 0 | 63 |
| 2021 | 1 | — | 0 | 77 |
| 2022 | 0 | — | 0 | 69 |
| 2023 | 0 | — | 0 | 69 |
| 2024 | 0 | — | 0 | 78 |
| 2025 | 0 | — | 0 | 127 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Coeur Front Load Injector Retrofit Kit is intended to be used with Medrad MCT and MCT Plus Injectors to hold the Coeur 200 mL Front Load Syringe in place in front of the Injector Ram during the injection of contrast media into the vascular system for diagnostic purposes.
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/K965214 · printed Nov 5, 2026
Cite this page
510(k) Report. “K965214: Coeur Front Load Injector Retrofit Kit (C859-0002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965214
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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