510(k) · Cleared
ClearedBard Eagle Inflation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ryder Intl. Corp. · KOE Dilator, Urethral
Cleared on Oct 21, 1996 as substantially equivalent to K953522 (Ryder Intl. Corp., 1996) after a 110-day review. Its family tree reaches back 1 generation to 1996. 12 later devices descend from it.
- Decided
- Oct 21, 1996
- Review
- 110 days
- Class
- Class II
- Product code
- KOE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953522 (1996). 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK953522 Usci Ideal Ptca KitRyder Intl. Corp. · 1996
- This deviceK962611 Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996
- Descendant · cites it directly · 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 · 2 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
- Descendant · 2 generations on · 0 of its ownK181713 Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated · 2018
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K972964Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997 · cites it directly11descendants
- K032840Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004 · cites it directly6descendants
- K020333Atrion Medical QL Fluid Dispensing SyringeAtrion Medical Products, Inc. · 2002 · 2 generations on2descendants
- K103231Kyphon Inflation SyringeMedtronic Spine, LLC · 2011 · 2 generations on1descendant
- K181713Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953522 | Usci Ideal Ptca Kit | Ryder Intl. Corp. | 1996 | — |
| 0 (this device) | K962611 | Bard Eagle Inflation Device | Ryder Intl. Corp. | 1996 | — |
| +1 | K972964 | Atrion Medical Balloon Catheter Inflation Device | Atrion Medical Products, Inc. | 1997 | — |
| +1 | K032840 | Atrion Medical QL Inflation Device | Atrion Medical Products, Inc. | 2004 | — |
| +2 | K020333 | Atrion Medical QL Fluid Dispensing Syringe | Atrion Medical Products, Inc. | 2002 | — |
| +2 | K103231 | Kyphon Inflation Syringe | Medtronic Spine, LLC | 2011 | — |
| +2 | K181713 | Ultraxx Nephrostomy Balloon Catheter Set | Cook Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KOE? 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 KOE device
- #1 K191061 Optilume Basic Urological Balloon Dilation…score -0.8 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K953522 | Usci Ideal Ptca KitSummary page 1…, Arab, AL 35016 Telephone: (205) 586-1580 Fax: (205) 586-5553 Predicate: Ryder Intemational Balloon Catheter (USCI® Ideal ™) Inflation Device cleared for market under K953522. Device Description/ Intended Use: The Ryder Urological Balloon Catheter Inflation Device consists of a plastic syringe vith a… | 1996 |
What descends from it? (12)
See all 122 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?
How does its category compare?
All KOE devicesKOE Dilator, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOE
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KOE
Too few KOE 510(k)s in any year since 2007 to give a median.
Recalls per year · KOE
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOE
11in 2025
MAUDE reports naming product code KOE, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 0 | — | 2 | 20 |
| 2020 | 1 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 0 | — | 0 | 20 |
| 2024 | 0 | — | 0 | 22 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The inflation device is intended for single use while performing urological balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.
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/K962611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962611: Bard Eagle 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/K962611
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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