510(k) · Cleared
ClearedUsci Ideal Ptca Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ryder Intl. Corp. · MAV Syringe, Balloon Inflation
Cleared on Apr 17, 1996 after a 265-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.
- Decided
- Apr 17, 1996
- Review
- 265 days
- Class
- Class II
- Product code
- MAV
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK953522 Usci Ideal Ptca KitRyder Intl. Corp. · 1996
- Descendant · cites it directly · 12 of its ownK962611 Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996
- Descendant · 2 generations on · 11 of its ownK972964 Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997
- Descendant · cites it directly · 6 of its ownK032840 Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004
- Descendant · 3 generations on · 2 of its ownK020333 Atrion Medical QL Fluid Dispensing SyringeAtrion Medical Products, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK103231 Kyphon Inflation SyringeMedtronic Spine, LLC · 2011
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K962611Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996 · cites it directly12descendants
- K972964Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997 · 2 generations on11descendants
- K032840Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004 · cites it directly6descendants
- K020333Atrion Medical QL Fluid Dispensing SyringeAtrion Medical Products, Inc. · 2002 · 3 generations on2descendants
- K103231Kyphon Inflation SyringeMedtronic Spine, LLC · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953522 | Usci Ideal Ptca Kit | Ryder Intl. Corp. | 1996 | — |
| +1 | K962611 | Bard Eagle Inflation Device | Ryder Intl. Corp. | 1996 | — |
| +2 | K972964 | Atrion Medical Balloon Catheter Inflation Device | Atrion Medical Products, Inc. | 1997 | — |
| +1 | K032840 | Atrion Medical QL Inflation Device | Atrion Medical Products, Inc. | 2004 | — |
| +3 | K020333 | Atrion Medical QL Fluid Dispensing Syringe | Atrion Medical Products, Inc. | 2002 | — |
| +2 | K103231 | Kyphon Inflation Syringe | Medtronic Spine, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | — | Merit Medical Systems Monarch™ Balloon Catheter inflation Syringe Named without a submission number |
What descends from it? (13)
See all 132 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K962611 (Ryder Intl. Corp., 1996) has gone furthest, with 12 descendants of its own.
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?
The Ryder device is intended for single use inflating of a balloon catheter, monitoring the pressure within the catheter and deflating the balloon catheter during angioplasty procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K953522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953522: Usci Ideal Ptca Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953522
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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