510(k) · Cleared
ClearedAdvance Pressure Monitor/High Pressure Lines
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advance Medical Designs, Inc. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Jul 5, 1994 after a 1,163-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jul 5, 1994
- Review
- 1,163 days
- Class
- Class II
- Product code
- DTL
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK911884 Advance Pressure Monitor/High Pressure LinesAdvance Medical Designs, Inc. · 1994
- Descendant · cites it directly · 7 of its ownK963749 High Pressure Injection LinesMaxxim Medical · 1996
- Descendant · 2 generations on · 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 · 2 generations on · 1 of its ownK152387 Fluent Inflation DeviceVascular Solutions, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK162272 Fluent inflation deviceVascular Solutions, Inc. · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K963749High Pressure Injection LinesMaxxim Medical · 1996 · cites it directly7descendants
- K023591Ultra High Pressure Injector LinesDeroyal Industries, Inc. · 2003 · 2 generations on3descendants
- K071196Disposable High Pressure Injection Lines with and Without Rotating AdaptersCoeur, Inc. · 2007 · cites it directly2descendants
- K152387Fluent Inflation DeviceVascular Solutions, Inc. · 2015 · 2 generations on1descendant
- K162272Fluent inflation deviceVascular Solutions, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911884 | Advance Pressure Monitor/High Pressure Lines | Advance Medical Designs, Inc. | 1994 | — |
| +1 | 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 | — |
| +2 | K152387 | Fluent Inflation Device | Vascular Solutions, Inc. | 2015 | — |
| +3 | K162272 | Fluent inflation device | Vascular Solutions, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K963749 (Maxxim Medical, 1996) has gone furthest, with 7 descendants of its own.
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) | — |
https://510kreport.com/device/K911884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911884: Advance Pressure Monitor/High Pressure Lines.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911884
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026