510(k) · Cleared
ClearedUltra High Pressure Injector Lines
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Industries, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jun 18, 2003 as substantially equivalent to K822100 (Namic, 1982) and 1 other predicate after a 236-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Jun 18, 2003
- Review
- 236 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K911884 (1994). 3 ancestors in all, the oldest K822100 (1982). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK911884 Advance Pressure Monitor/High Pressure LinesAdvance Medical Designs, Inc. · 1994
- 1 generation backK963749 High Pressure Injection LinesMaxxim Medical · 1996
- This deviceK023591 Ultra High Pressure Injector LinesDeroyal Industries, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK071196 Disposable High Pressure Injection Lines with and Without Rotating…Coeur, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK140356 Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK131770 Pressure Connecting TubeShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2014
Most influential descendants
Showing 3 of 3 · See all- K071196Disposable High Pressure Injection Lines with and Without Rotating AdaptersCoeur, Inc. · 2007 · cites it directly2descendants
- K140356Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd. · 2015 · cites it directly0descendants
- K131770Pressure Connecting TubeShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911884 | Advance Pressure Monitor/High Pressure Lines | Advance Medical Designs, Inc. | 1994 | — |
| −1 | K963749 | High Pressure Injection Lines | Maxxim Medical | 1996 | — |
| 0 (this device) | 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 | — |
| +1 | K140356 | Summed High Pressure Line | Sunny Medical Device (Shenzhen) Co., Ltd. | 2015 | — |
| +2 | K131770 | Pressure Connecting Tube | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K822100 | High Pressure Contrast Injection LineSummary page 1…eous Catheter Class II device per 21 CFR 870.1250 PREDICATE OR LEGALLY MARKETED DEVICES - NAME flexCiL@ Contrast Injection Lines (K822100) Maxxim Medicel Inc. - High Pressure Lines (K963749) DEVICE DESCRIPTION me DeRoyal Industrles, Inc. Ultra Hlgh Pressure Injecto… | 1982 |
| * | K963749 | High Pressure Injection LinesSummary page 1…vice per 21 CFR 870.1250 PREDICATE OR LEGALLY MARKETED DEVICES - NAME flexCiL@ Contrast Injection Lines (K822100) Maxxim Medicel Inc. - High Pressure Lines (K963749) DEVICE DESCRIPTION me DeRoyal Industrles, Inc. Ultra Hlgh Pressure Injector Lines are comprised of PVC tubing ranging in lengt… | 1996 |
What descends from it? (3)
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 9 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K071196 (Coeur, Inc., 2007) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K822100.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DeRoyal Industries, Inc., Ultra High Pressure Injector Lines are indicated for use
during coronary angiography procedures as a connecting line for the injection of radio-opaque dye or saline.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023591: Ultra High Pressure Injector Lines.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023591
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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