510(k) · Cleared
Recalled · Class II · 2012Sedat Flamingo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sedat · MAV Syringe, Balloon Inflation
Cleared on Dec 15, 2008 as substantially equivalent to K042449 (Sedat S.A., 2005) after an 87-day review. Its family tree reaches back 4 generations to 1985. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 15, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- MAV
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K854261 (1985). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 3 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- 2 generations backK040498 MyshellSedat S.A. · 2004
- 1 generation backK042449 Dolphin Inflation DeviceSedat S.A. · 2005 · Recalled
- This deviceK082755 Sedat FlamingoSedat · 2008
- 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 · cites it directly · 0 of its ownK123831 Ophtacath KitFrance Chirurgae Instrumentation · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −3 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| −2 | K040498 | Myshell | Sedat S.A. | 2004 | — |
| −1 | K042449 | Dolphin Inflation Device | Sedat S.A. | 2005 | 4 |
| 0 (this device) | K082755 | Sedat Flamingo | Sedat | 2008 | — |
| +1 | K152387 | Fluent Inflation Device | Vascular Solutions, Inc. | 2015 | — |
| +2 | K162272 | Fluent inflation device | Vascular Solutions, Inc. | 2016 | — |
| +1 | K123831 | Ophtacath Kit | France Chirurgae Instrumentation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K042449 | Dolphin Inflation DeviceSummary page 1…: 870.1650 Product Code: MAY C. Predicate Devices The subject device is substantially equivalent to Sedat's Dolphin Device (K042449). D. Device Description The Sedat Flamingo inflation device is a single-use, sterile, and ergonomically designed… | 2005 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2012 | Class II | Z-2089-2014 | Process control | Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air entry when the plunger is positioned… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K152387 (Vascular Solutions, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K042449.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Sedat Flamingo is indicated for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082755 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082755: Sedat Flamingo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082755
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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