510(k) · Cleared
Recalled · Class II · 2017Dolphin Inflation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sedat S.A. · MAV Syringe, Balloon Inflation
Cleared on Apr 18, 2005 as substantially equivalent to K961471 (Advanced Cardiovascular Systems, Inc., 1996) and 1 other predicate after a 221-day review. Its family tree reaches back 3 generations to 1985. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 18, 2005
- Review
- 221 days
- Class
- Class II
- Product code
- MAV
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 3 generations to K854261 (1985). 6 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 2 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- 1 generation backK040498 MyshellSedat S.A. · 2004
- This deviceK042449 Dolphin Inflation DeviceSedat S.A. · 2005
- Descendant · cites it directly · 3 of its ownK082755 Sedat FlamingoSedat · 2008 · Recalled
- 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
- Descendant · 2 generations on · 0 of its ownK123831 Ophtacath KitFrance Chirurgae Instrumentation · 2013
- Descendant · cites it directly · 0 of its ownK122152 Oxti Inflation DeviceOxti Corporation · 2012
Most influential descendants
Showing 5 of 5 · See all- K082755Sedat FlamingoSedat · 2008 · cites it directly3descendants
- K152387Fluent Inflation DeviceVascular Solutions, Inc. · 2015 · 2 generations on1descendant
- K162272Fluent inflation deviceVascular Solutions, Inc. · 2016 · 3 generations on0descendants
- K123831Ophtacath KitFrance Chirurgae Instrumentation · 2013 · 2 generations on0descendants
- K122152Oxti Inflation DeviceOxti Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −2 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| −1 | K040498 | Myshell | Sedat S.A. | 2004 | — |
| 0 (this device) | K042449 | Dolphin Inflation Device | Sedat S.A. | 2005 | — |
| +1 | K082755 | Sedat Flamingo | Sedat | 2008 | 1 |
| +2 | K152387 | Fluent Inflation Device | Vascular Solutions, Inc. | 2015 | — |
| +3 | K162272 | Fluent inflation device | Vascular Solutions, Inc. | 2016 | — |
| +2 | K123831 | Ophtacath Kit | France Chirurgae Instrumentation | 2013 | — |
| +1 | K122152 | Oxti Inflation Device | Oxti Corporation | 2012 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K961471 | Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115…Summary page 4…DOLPHIN is substantially equivalent, with respect to the intended use, conditions Substantial of use, and design, of the currently marketed Indeflator 20/30 (K961471, Product Equivalence Code: MAX, Regulation: 870.1650). The DOLPHIN is substantial equivalent, wi… | 1996 |
| * | K040498 | MyshellSummary page 4…OLPHIN is substantial equivalent, with respect to materials, packaging process and location, as well as sterilization and location, to the Myshell (K040498, Product Code: DTL, Regulation: 870.4290). Device Description DOLPHIN is a single-use, sterile, and erg… | 2004 |
What descends from it? (5)
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 |
|---|---|---|---|---|
| Jun 7, 2017 | Class II | Z-2639-2017 | Unknown/Undetermined by firm | Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility |
| Apr 12, 2017 | Class II | Z-2180-2017 | Packaging | The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Use of affected product could pose a risk of microbial contamination, leading to… |
| Apr 5, 2017 | Class II | Z-1891-2017 | Packaging change control | Complaints regarding broken blister. |
| Oct 6, 2014 | Class II | Z-0876-2015 | Device Design | Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K082755 (Sedat, 2008) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K961471.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
DOLPHIN lnflation Device is intended 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/K042449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042449: Dolphin 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/K042449
Report an extraction error
Are you the manufacturer?
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