510(k) · Cleared
ClearedSummed High Pressure Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunny Medical Device (Shenzhen) Co., Ltd. · DQO Catheter, Intravascular, Diagnostic
Cleared on Mar 20, 2015 as substantially equivalent to K071196 (Coeur, Inc., 2007) and 1 other predicate after a 401-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Mar 20, 2015
- Review
- 401 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K911884 (1994). 6 ancestors in all, the oldest K810924 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK911884 Advance Pressure Monitor/High Pressure LinesAdvance Medical Designs, Inc. · 1994
- 3 generations backK963749 High Pressure Injection LinesMaxxim Medical · 1996
- 2 generations backK023591 Ultra High Pressure Injector LinesDeroyal Industries, Inc. · 2003
- 1 generation backK071196 Disposable High Pressure Injection Lines with and Without Rotating…Coeur, Inc. · 2007
- This deviceK140356 Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911884 | Advance Pressure Monitor/High Pressure Lines | Advance Medical Designs, Inc. | 1994 | — |
| −3 | K963749 | High Pressure Injection Lines | Maxxim Medical | 1996 | — |
| −2 | K023591 | Ultra High Pressure Injector Lines | Deroyal Industries, Inc. | 2003 | — |
| −1 | K071196 | Disposable High Pressure Injection Lines with and Without Rotating Adapters | Coeur, Inc. | 2007 | — |
| 0 (this device) | K140356 | Summed High Pressure Line | Sunny Medical Device (Shenzhen) Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K071196 | Disposable High Pressure Injection Lines with and Without Rotating AdaptersSummary page 4…Trade or Proprietary or Model Name Manufacturer Number Disposable High Pressure Injection Coeur Medical, a division K071196 Lines and without Rotating Adapters of Coeur Inc. K023591 Ultra High Pressure Inj… | 2007 |
| * | K023591 | Ultra High Pressure Injector LinesSummary page 4…Disposable High Pressure Injection Coeur Medical, a division K071196 Lines and without Rotating Adapters of Coeur Inc. K023591 Ultra High Pressure Injector Lines DeRoyal Industries, Inc. Sunny Medical Device (Shenzhen) Co., Ltd.… | 2003 |
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 21 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K071196.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The SunmedTM High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140356: Summed High Pressure Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140356
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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