510(k) · Cleared
ClearedAtrion Medical QL 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 Mar 3, 2004 as substantially equivalent to K972964 (Atrion Medical Products, Inc., 1997) and 3 other predicates after a 174-day review. Its family tree reaches back 3 generations to 1996. 6 later devices descend from it.
- Decided
- Mar 3, 2004
- Review
- 174 days
- Class
- Class II
- Product code
- KOE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K953522 (1996). 4 ancestors in all, the oldest K955869 (1996). 6 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK953522 Usci Ideal Ptca KitRyder Intl. Corp. · 1996
- 2 generations backK962611 Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996
- 1 generation backK972964 Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997
- This deviceK032840 Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK103231 Kyphon Inflation SyringeMedtronic Spine, LLC · 2011
- Descendant · cites it directly · 0 of its ownK181713 Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK140943 Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015
- Descendant · cites it directly · 0 of its ownK133795 Summed Inflation Device KitSunny Medical Device (Shenzhen) Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK113742 KMC Kyphoplasty SystemShanghai Kinetic Medical Co., Ltd. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K103231Kyphon Inflation SyringeMedtronic Spine, LLC · 2011 · cites it directly1descendant
- K181713Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated · 2018 · cites it directly0descendants
- K140943Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015 · cites it directly0descendants
- K133795Summed Inflation Device KitSunny Medical Device (Shenzhen) Co., Ltd. · 2014 · cites it directly0descendants
- K113742KMC Kyphoplasty SystemShanghai Kinetic Medical Co., Ltd. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953522 | Usci Ideal Ptca Kit | Ryder Intl. Corp. | 1996 | — |
| −2 | K962611 | Bard Eagle Inflation Device | Ryder Intl. Corp. | 1996 | — |
| −1 | K972964 | Atrion Medical Balloon Catheter Inflation Device | Atrion Medical Products, Inc. | 1997 | — |
| 0 (this device) | K032840 | Atrion Medical QL Inflation Device | Atrion Medical Products, Inc. | 2004 | — |
| +1 | K103231 | Kyphon Inflation Syringe | Medtronic Spine, LLC | 2011 | — |
| +1 | K181713 | Ultraxx Nephrostomy Balloon Catheter Set | Cook Incorporated | 2018 | — |
| +1 | K140943 | Mastro Plus Balloon in-Deflation Device | Beijing Demax Medical Technology Co.,Ltd | 2015 | — |
| +1 | K133795 | Summed Inflation Device Kit | Sunny Medical Device (Shenzhen) Co., Ltd. | 2014 | — |
| +2 | K113742 | KMC Kyphoplasty System | Shanghai Kinetic Medical Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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? (4)
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 |
|---|---|---|---|
| * | K972964 | Atrion Medical Balloon Catheter Inflation DeviceSummary page 1…(256) 586-8529 Email: dclark~atrionmedical.com Predicates: Atrion Medical Products Balloon Catheter Inflation Device, K972964. Ryder International (Bard Eagle) Urological Balloon Catheter Inflation Device, K96261 1 R… | 1997 |
| * | K962611 | Bard Eagle Inflation DeviceSummary page 1…ion Medical Products Balloon Catheter Inflation Device, K972964. Ryder International (Bard Eagle) Urological Balloon Catheter Inflation Device, K96261 1 Ryder International (UISCI Ideal) Balloon Catheter Inflation Device, K953522 Scimed Encore 26 and Encor… | 1996 |
| * | K953522 | Usci Ideal Ptca KitSummary page 1…tional (Bard Eagle) Urological Balloon Catheter Inflation Device, K96261 1 Ryder International (UISCI Ideal) Balloon Catheter Inflation Device, K953522 Scimed Encore 26 and Encore 30 Inflation Devices, K955869 Device Description: The Atrion Medical QL® I… | 1996 |
| * | K955869 | Scimed Encore 26 Inflation Device/Encore 30 Inflation DeviceSummary page 1…K96261 1 Ryder International (UISCI Ideal) Balloon Catheter Inflation Device, K953522 Scimed Encore 26 and Encore 30 Inflation Devices, K955869 Device Description: The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type p… | 1996 |
What descends from it? (6)
5 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 8 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K103231 (Medtronic Spine, LLC, 2011) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K972964.
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 recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032840: Atrion Medical QL 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/K032840
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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