510(k) · Cleared
ClearedPressure Sensing Syringe 65000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dlp, Inc. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Nov 14, 1985 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Nov 14, 1985
- Review
- 80 days
- Class
- Class II
- Product code
- DTL
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK853586 Pressure Sensing Syringe 65000Dlp, Inc. · 1985
- Descendant · cites it directly · 5 of its ownK082725 Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK091733 Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC · 2009 · Recalled
- Descendant · 3 generations on · 0 of its ownK191947 VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension…Maquet Cardiovascular, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK140603 Onepass Endoscopic Vessel Harvesting SysyetmSaphena Medical, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK131659 Moerae Vein Preparation KitMoerae Matrix, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K082725Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC · 2008 · cites it directly5descendants
- K091733Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC · 2009 · 2 generations on2descendants
- K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension…Maquet Cardiovascular, LLC · 2019 · 3 generations on0descendants
- K140603Onepass Endoscopic Vessel Harvesting SysyetmSaphena Medical, Inc. · 2014 · 3 generations on0descendants
- K131659Moerae Vein Preparation KitMoerae Matrix, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K853586 | Pressure Sensing Syringe 65000 | Dlp, Inc. | 1985 | — |
| +1 | K082725 | Graftguard Pressure Controlling Syringe | Maquet Cardiovascular, LLC | 2008 | 1 |
| +2 | K091733 | Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500 | Maquet Cardiovascular, LLC | 2009 | 1 |
| +3 | K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar… | Maquet Cardiovascular, LLC | 2019 | — |
| +3 | K140603 | Onepass Endoscopic Vessel Harvesting Sysyetm | Saphena Medical, Inc. | 2014 | 1 |
| +2 | K131659 | Moerae Vein Preparation Kit | Moerae Matrix, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2019 | 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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082725 | Graftguard Pressure Controlling Syringe | 2008 | 5 |
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, K082725 (Maquet Cardiovascular, LLC, 2008) has gone furthest, with 5 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/K853586 · printed Nov 4, 2026
Cite this page
510(k) Report. “K853586: Pressure Sensing Syringe 65000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853586
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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