510(k) · Decided
DecidedFluent Inflation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · MAV Syringe, Balloon Inflation
Cleared on Dec 18, 2015 as substantially equivalent to K082755 (Sedat, 2008) and 1 other predicate after a 116-day review. Its family tree reaches back 5 generations to 1985. 1 later device descends from it.
- Decided
- Dec 18, 2015
- Review
- 116 days
- Class
- Class II
- Product code
- MAV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K854261 (1985). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 4 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- 3 generations backK040498 MyshellSedat S.A. · 2004
- 2 generations backK042449 Dolphin Inflation DeviceSedat S.A. · 2005 · Recalled
- 1 generation backK082755 Sedat FlamingoSedat · 2008 · Recalled
- This deviceK152387 Fluent Inflation DeviceVascular Solutions, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK162272 Fluent inflation deviceVascular Solutions, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K162272Fluent inflation deviceVascular Solutions, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −4 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| −3 | K040498 | Myshell | Sedat S.A. | 2004 | — |
| −2 | K042449 | Dolphin Inflation Device | Sedat S.A. | 2005 | 4 |
| −1 | K082755 | Sedat Flamingo | Sedat | 2008 | 1 |
| 0 (this device) | K152387 | Fluent Inflation Device | Vascular Solutions, Inc. | 2015 | — |
| +1 | K162272 | Fluent inflation device | Vascular Solutions, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MAV? 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 MAV device
- #1 K260035 Digital Indeflator INFLANTEscore 12.6 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K082755 | Sedat FlamingoSummary page 4…on device Common / Usual Name Inflation device Classification Name 21 CFR 870.1650, MAV – Syringe, balloon inflation Predicate Devices K082755 – Sedat Flamingo (Sedat) K963749 – High Pressure Injection Lines (Maxxim Medical) Device Descrip… | 2008 |
| * | K963749 | High Pressure Injection LinesSummary page 4…sification Name 21 CFR 870.1650, MAV – Syringe, balloon inflation Predicate Devices K082755 – Sedat Flamingo (Sedat) K963749 – High Pressure Injection Lines (Maxxim Medical) Device Description The Fluent inflation device consists of a barrel with a plu… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162272 | Fluent inflation device | 2016 | 0 |
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 30 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K162272 (Vascular Solutions, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082755.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MAV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MAV
69in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAV
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAV
66in 2025
MAUDE reports naming product code MAV, 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 | 0 | — | 0 | 37 |
| 2008 | 1 | — | 0 | 50 |
| 2009 | 0 | — | 0 | 99 |
| 2010 | 0 | — | 3 | 88 |
| 2011 | 1 | — | 0 | 94 |
| 2012 | 4 | 85 | 0 | 251 |
| 2013 | 1 | — | 0 | 245 |
| 2014 | 2 | — | 2 | 92 |
| 2015 | 3 | 116 | 0 | 121 |
| 2016 | 3 | 69 | 1 | 124 |
| 2017 | 0 | — | 0 | 246 |
| 2018 | 0 | — | 1 | 300 |
| 2019 | 0 | — | 0 | 199 |
| 2020 | 0 | — | 0 | 101 |
| 2021 | 0 | — | 0 | 186 |
| 2022 | 1 | — | 5 | 437 |
| 2023 | 0 | — | 0 | 220 |
| 2024 | 0 | — | 4 | 420 |
| 2025 | 0 | — | 0 | 66 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter. The sidearm extension tubing is intended to provide a sterile fluid pathway between two devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152387: Fluent Inflation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152387
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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