510(k) · Cleared
ClearedHigh Pressure Injection Lines
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxxim Medical · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Dec 17, 1996 as substantially equivalent to K911884 (Advance Medical Designs, Inc., 1994) after a 90-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it.
- Decided
- Dec 17, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- DTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911884 (1994). 7 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK911884 Advance Pressure Monitor/High Pressure LinesAdvance Medical Designs, Inc. · 1994
- This deviceK963749 High Pressure Injection LinesMaxxim Medical · 1996
- Descendant · cites it directly · 3 of its ownK023591 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 · 1 of its ownK152387 Fluent Inflation DeviceVascular Solutions, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK162272 Fluent inflation deviceVascular Solutions, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK140356 Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K023591Ultra High Pressure Injector LinesDeroyal Industries, Inc. · 2003 · cites it directly3descendants
- K071196Disposable High Pressure Injection Lines with and Without Rotating AdaptersCoeur, Inc. · 2007 · cites it directly2descendants
- K152387Fluent Inflation DeviceVascular Solutions, Inc. · 2015 · cites it directly1descendant
- K162272Fluent inflation deviceVascular Solutions, Inc. · 2016 · 2 generations on0descendants
- K140356Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911884 | Advance Pressure Monitor/High Pressure Lines | Advance Medical Designs, Inc. | 1994 | — |
| 0 (this device) | K963749 | High Pressure Injection Lines | Maxxim Medical | 1996 | — |
| +1 | 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 | K152387 | Fluent Inflation Device | Vascular Solutions, Inc. | 2015 | — |
| +2 | K162272 | Fluent inflation device | Vascular Solutions, Inc. | 2016 | — |
| +2 | K140356 | Summed High Pressure Line | Sunny Medical Device (Shenzhen) Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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 DTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K911884 | Advance Pressure Monitor/High Pressure LinesSummary page 1…mon Name: High Pressure Injection Line Classification Name: Cardiopulmonary bypass adaptor, stopcock, manifold or fitting PREDICATE DEVICE Advance High Pressure Lines; K911884; Advance Medical, Inc. DEVICE DESCRIPTION The High Pressure Line is a device used as conduit tubing to deliver fluids from an e… | 1994 |
What descends from it? (7)
4 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?
How does its category compare?
All DTL devicesDTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DTL
36in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTL
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DTL
110in 2025
MAUDE reports naming product code DTL, 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 | 1 | — | 0 | 37 |
| 2008 | 5 | 85 | 1 | 16 |
| 2009 | 2 | — | 0 | 62 |
| 2010 | 4 | 115 | 3 | 148 |
| 2011 | 0 | — | 1 | 160 |
| 2012 | 8 | 36 | 2 | 53 |
| 2013 | 1 | — | 1 (1) | 67 |
| 2014 | 2 | — | 1 | 80 |
| 2015 | 1 | — | 0 | 89 |
| 2016 | 0 | — | 0 | 67 |
| 2017 | 0 | — | 2 | 106 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 2 | 48 |
| 2023 | 0 | — | 0 | 46 |
| 2024 | 0 | — | 0 | 452 |
| 2025 | 0 | — | 1 | 110 |
| 2026 | 0 | — | 3 (3) | — |
What is it indicated for?
Conduit tubing to deliver fluids from an electronic or manual injector; connector tubing to provide a sterile fluid pathway between two devices.
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/K963749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963749: High Pressure Injection Lines.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963749
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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