510(k) · Cleared
ClearedElph Injection System
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 Jul 26, 2002 as substantially equivalent to K912944 (Mallinckrodt Group, Inc., 1992) after a 25-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jul 26, 2002
- Review
- 25 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912944 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK912944 CT 8000 Digital Injection SystemMallinckrodt Group, Inc. · 1992 · Recalled
- This deviceK022116 Elph Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912944 | CT 8000 Digital Injection System | Mallinckrodt Group, Inc. | 1992 | 1 |
| 0 (this device) | K022116 | Elph Injection System | Mallinckrodt Inc., Liebel-Flarsheim Business | 2002 | — |
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 |
|---|---|---|---|
| * | K912944 | CT 8000 Digital Injection SystemSummary page 2…These syringes are commonplace on the market. 8. Substantial Equivalence The Predicate device to the ELPH Injection System is the CT 8000 Digital Injection System (K912944), currently marketed under the name CT 9000ADV. The predicate device is designed to meet both the ordinary needs of the market as… | 1992 |
| † | K860204 | Angiomat 6000 | 1986 |
| † | K984088 | Optistar MR Injector System | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 5 other devices also cite its predicate K912944.
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 ELPH Injection System is a contiast delivery system which is designed to inject radiopaque contrast media into a patient’s vascular system to obtain diagnostic images when used with computed tomography (i.e. “CT”) equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022116: Elph Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022116
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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