510(k) · Cleared
Recalled · 2010Amplatzer Sizing Balloon II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aga Medical Corp. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Dec 30, 2005 as substantially equivalent to K993248 (Aga Medical Corp., 2000) and 1 other predicate after a 21-day review. Its family tree reaches back 3 generations to 1994. It has been recalled 2 times.
- Decided
- Dec 30, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- MJN
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K941269 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK941269 Gore Smoother II and Gore BPTBW. L. Gore & Associates, Inc. · 1994
- 2 generations backK962765 Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque…Cordis Corp. · 1997
- 1 generation backK993248 Amplatzer Sizing BalloonAga Medical Corp. · 2000
- This deviceK053440 Amplatzer Sizing Balloon IIAga Medical Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941269 | Gore Smoother II and Gore BPTB | W. L. Gore & Associates, Inc. | 1994 | — |
| −2 | K962765 | Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers)… | Cordis Corp. | 1997 | — |
| −1 | K993248 | Amplatzer Sizing Balloon | Aga Medical Corp. | 2000 | — |
| 0 (this device) | K053440 | Amplatzer Sizing Balloon II | Aga Medical Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 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 MJN? 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 MJN device
- #1 K243795 pREBOA-PRO Catheterscore 12.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K993248 | Amplatzer Sizing BalloonSummary page 2…to currently marketed balloon catheters for temporary vessel occlusion: - AMPLATZER Sizing Balloon (K993248) - Numed PTA-OS Sizing Balloon (K003320) Performance Standards: No performance st… | 2000 |
| * | K003320 | Pta-OS Sizing Balloon, Model 360Summary page 2…for temporary vessel occlusion: - AMPLATZER Sizing Balloon (K993248) - Numed PTA-OS Sizing Balloon (K003320) Performance Standards: No performance standards have been developed under sectio… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2010 | Not classified | Z-1595-2011 | Employee error | AGA Medical is initiating a voluntary recall of a specific lot of mislabeled AMPLATZER Sizing Balloon II. AGA Medical received 2 reports from customers who received sizing balloons that were labeled as 34 mm; however, the package… |
| Apr 25, 2008 | Not classified | Z-2193-2008 | Packaging process control | AGA Medical Corporation has identified an issue with outer pouch seal integrity within one production lot of 10 French 45/80 delivery systems and one lot of 24 mm Sizing Balloon. We have not observed incomplete seals with the inner pouch.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MJN
116in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MJN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJN
194in 2025
MAUDE reports naming product code MJN, 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 | 2 | — | 0 | 25 |
| 2008 | 3 | 153 | 2 | 26 |
| 2009 | 5 | 39 | 0 | 25 |
| 2010 | 5 | 30 | 1 | 35 |
| 2011 | 4 | 69 | 1 | 92 |
| 2012 | 2 | — | 0 | 53 |
| 2013 | 4 | 87 | 8 | 76 |
| 2014 | 2 | — | 0 | 100 |
| 2015 | 4 | 245 | 1 | 90 |
| 2016 | 3 | 110 | 2 | 71 |
| 2017 | 3 | 54 | 0 | 157 |
| 2018 | 3 | 63 | 1 | 107 |
| 2019 | 3 | 117 | 0 | 139 |
| 2020 | 4 | 64 | 1 | 157 |
| 2021 | 4 | 116 | 0 | 158 |
| 2022 | 2 | — | 0 | 148 |
| 2023 | 1 | — | 0 | 181 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 2 | — | 0 | 194 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AMPLATZER® Sizing Balloon II is indicated for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053440 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053440: Amplatzer Sizing Balloon II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053440
Report an extraction error
Are you the manufacturer?
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