510(k) · Cleared
ClearedDisposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fortis Biosolutions Company Limited · DXT Injector And Syringe, Angiographic
Cleared on May 14, 2026 as substantially equivalent to K192657 (Shenzhen Boon Medical Supply Co., Ltd., 2020) after a 265-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- May 14, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K934086 (1995). 21 ancestors in all, the oldest K822536 (1982). No later device cites it as a predicate yet.
- Root · 8 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 7 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- 6 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
- 5 generations backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- 4 generations backK051799 Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
- 3 generations backK072696 Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008
- 2 generations backK151960 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016
- 1 generation backK192657 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2020
- This deviceK252652 Disposable Syringes with Accessories for Power Injectors (900103T)…Fortis Biosolutions Company Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −7 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| −6 | K023183 | Medrad Stellant CT Injector System | Medrad, Inc. | 2003 | 6 |
| −5 | K033881 | Medrad Stellant CT Injector System with Imaging System Interface Module | Medrad, Inc. | 2004 | 1 |
| −4 | K051799 | Disposable CT/MR Syringes for Nemoto Injectors | Coeur, Inc. | 2005 | — |
| −3 | K072696 | Ant Angiographic Syringes, Model (S)… | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2008 | — |
| −2 | K151960 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Baoan Medical Supplies Co., Ltd. | 2016 | — |
| −1 | K192657 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | 2020 | — |
| 0 (this device) | K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable… | Fortis Biosolutions Company Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K192657 | Sterile High-pressure Angiographic Syringes for Single-useSummary page 6…yringes with Accessories for Power Injectors 510(K) Summary 5. Identification of the predicate device 510(k) Number: K192657 Predicate Trade Name: Sterile High-pressure Angiographic Syring… | 2020 |
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?
- The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 4.4 years on median.
- 5 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K192657.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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 proposed device is intended for the injection of contrast media or saline; it shall be used with US legally marketed angiographic injectors.
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/K252652 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252652: Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252652
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026