510(k) · Cleared
ClearedAtrion Medical Balloon Catheter Inflation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrion Medical Products, Inc. · KOE Dilator, Urethral
Cleared on Oct 10, 1997 as substantially equivalent to K962611 (Ryder Intl. Corp., 1996) after a 60-day review. Its family tree reaches back 2 generations to 1996. 11 later devices descend from it.
- Decided
- Oct 10, 1997
- Review
- 60 days
- Class
- Class II
- Product code
- KOE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953522 (1996). 11 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK953522 Usci Ideal Ptca KitRyder Intl. Corp. · 1996
- 1 generation backK962611 Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996
- This deviceK972964 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 · cites it directly · 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
- Descendant · 2 generations on · 0 of its ownK140943 Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K032840Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004 · cites it directly6descendants
- K020333Atrion Medical QL Fluid Dispensing SyringeAtrion Medical Products, Inc. · 2002 · cites it directly2descendants
- K103231Kyphon Inflation SyringeMedtronic Spine, LLC · 2011 · 2 generations on1descendant
- K181713Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated · 2018 · 2 generations on0descendants
- K140943Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953522 | Usci Ideal Ptca Kit | Ryder Intl. Corp. | 1996 | — |
| −1 | K962611 | Bard Eagle Inflation Device | Ryder Intl. Corp. | 1996 | — |
| 0 (this device) | K972964 | Atrion Medical Balloon Catheter Inflation Device | Atrion Medical Products, Inc. | 1997 | — |
| +1 | K032840 | Atrion Medical QL Inflation Device | Atrion Medical Products, Inc. | 2004 | — |
| +1 | 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 | — |
| +2 | K140943 | Mastro Plus Balloon in-Deflation Device | Beijing Demax Medical Technology Co.,Ltd | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K962611 | Bard Eagle Inflation DeviceSummary page 1…d Arab, AL 35016 Telephone: (205) 586-1580, Fax: (205) 586-5553 Predicate: Ryder International Urological Balloon Catheter (Bard® Eagle™) Inflation Device cleared under K962611. Device Description/intended Use: The Atrion Medical Balloon Catheter Inflation Device consists of a plastic syringe with a scr… | 1996 |
What descends from it? (11)
See all 113 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?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 12 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K032840 (Atrion Medical Products, Inc., 2004) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K962611.
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 gastrointestinal (GI), gastrouterine (GU) and lacrimal duct balloon catheter 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/K972964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972964: Atrion Medical Balloon Catheter 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/K972964
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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