510(k) · Cleared
ClearedSterile High-pressure Angiographic Syringes for Single-use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Boon Medical Supply Co., Ltd. · DXT Injector And Syringe, Angiographic
Cleared on Aug 7, 2020 as substantially equivalent to K151960 (Shenzhen Baoan Medical Supplies Co., Ltd., 2016) after a 317-day review. Its family tree reaches back 7 generations to 1995. 4 later devices descend from it.
- Decided
- Aug 7, 2020
- Review
- 317 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K934086 (1995). 20 ancestors in all, the oldest K822536 (1982). 4 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 6 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- 5 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
- 4 generations backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- 3 generations backK051799 Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
- 2 generations backK072696 Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008
- 1 generation backK151960 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016
- This deviceK192657 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK211564 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK252652 Disposable Syringes with Accessories for Power Injectors (900103T)…Fortis Biosolutions Company Limited · 2026
- Descendant · 2 generations on · 0 of its ownK253048 High Pressure Syringe; Pressure Connecting Tube; Quick fill tube…Shenzhen Maiwei Biotech Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK241109 Single-use Sterile High-pressure Angiographic Syringes and AccessoriesShenzhen Boon Medical Supply Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2021 · cites it directly2descendants
- K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…Fortis Biosolutions Company Limited · 2026 · cites it directly0descendants
- K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd. · 2026 · 2 generations on0descendants
- K241109Single-use Sterile High-pressure Angiographic Syringes and AccessoriesShenzhen Boon Medical Supply Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −6 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| −5 | K023183 | Medrad Stellant CT Injector System | Medrad, Inc. | 2003 | 6 |
| −4 | K033881 | Medrad Stellant CT Injector System with Imaging System Interface Module | Medrad, Inc. | 2004 | 1 |
| −3 | 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 | — |
| −1 | K151960 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Baoan Medical Supplies Co., Ltd. | 2016 | — |
| 0 (this device) | K192657 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | 2020 | — |
| +1 | K211564 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | 2021 | — |
| +1 | K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable… | Fortis Biosolutions Company Limited | 2026 | — |
| +2 | K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike… | Shenzhen Maiwei Biotech Co., Ltd. | 2026 | — |
| +2 | K241109 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | Shenzhen Boon Medical Supply Co., Ltd. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K151960 | Sterile High-pressure Angiographic Syringes for Single-useSummary page 8…700107-2 / set with Check valve 5. Identification of Predicate Device 510(k) Number: K151960 Product Name: Sterile High-pressure Angiographic Syringes for Single-use Manufacturer: Shenzhen Boon Medical Su… | 2016 |
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?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 5 of the 20 ancestors have a recall of any class.
- Of its descendants, K211564 (Shenzhen Boon Medical Supply Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K151960.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192657: Sterile High-pressure Angiographic Syringes for Single-use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192657
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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