510(k) · Cleared
ClearedPresto Inflation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · MAV Syringe, Balloon Inflation
Cleared on Jan 12, 2015 as substantially equivalent to K955869 (Scimed Life Systems, Inc., 1996) after a 31-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jan 12, 2015
- Review
- 31 days
- Class
- Class II
- Product code
- MAV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955869 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955869 Scimed Encore 26 Inflation Device/Encore 30 Inflation DeviceScimed Life Systems, Inc. · 1996 · Recalled
- This deviceK143522 Presto Inflation DeviceC.R. Bard, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955869 | Scimed Encore 26 Inflation Device/Encore 30 Inflation Device | Scimed Life Systems, Inc. | 1996 | 1 |
| 0 (this device) | K143522 | Presto Inflation Device | C.R. Bard, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K955869 | Scimed Encore 26 Inflation Device/Encore 30 Inflation DeviceSummary page 4…duct Code: MAV) Classification: Class II Classification Panel: Cardiovascular Predicate Device: SCIMED Encore Inflation Devices (K955869; cleared March 22, 1996) . Bard Peripheral Vascular, Inc.… | 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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K955869.
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 Presto™ Inflation Device is indicated for use with angioplasty balloon dilatation catheters to create and monitor the pressure in the angioplasty balloon dilatation catheter and to deflate the angioplasty balloon dilatation catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143522 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143522: Presto Inflation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143522
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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