510(k) · Cleared
ClearedOxti Inflation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxti Corporation · MAV Syringe, Balloon Inflation
Cleared on Dec 14, 2012 as substantially equivalent to K042449 (Sedat S.A., 2005) and 1 other predicate after a 147-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Dec 14, 2012
- Review
- 147 days
- Class
- Class II
- Product code
- MAV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K854261 (1985). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK122152 Oxti Inflation DeviceOxti Corporation · 2012
View 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) | 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 | 2 | 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 |
|---|---|---|---|
| * | K042449 | Dolphin Inflation DeviceSummary page 1…MAV 3. Predicate Device Trade Name 510(k) Number Decision Date Dolphin Inflation Device K(042449 5/20/2005 Indleflator Plus 30 Priority Pack K(962495 9/12/1996 K122152 4.… | 2005 |
| * | K962495 | Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating Hemostatic Valve)Summary page 1…510(k) Number Decision Date Dolphin Inflation Device K(042449 5/20/2005 Indleflator Plus 30 Priority Pack K(962495 9/12/1996 K122152 4. Device Description The device consists of three major components; a) 30m1… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 5 of the 8 ancestors have a recall of any class.
- 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. 2012, 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 OXTI Inflation Device is indicated for use during cardiovascular procedures to
create, maintain, and monitor pressure in the balloon dilation catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122152: Oxti 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/K122152
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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