510(k) · Cleared
ClearedAmplatzer Sizing Balloon
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 Jul 12, 2000 as substantially equivalent to K962765 (Cordis Corp., 1997) after a 288-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jul 12, 2000
- Review
- 288 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941269 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK941269 Gore Smoother II and Gore BPTBW. L. Gore & Associates, Inc. · 1994
- 1 generation backK962765 Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque…Cordis Corp. · 1997
- This deviceK993248 Amplatzer Sizing BalloonAga Medical Corp. · 2000
- Descendant · cites it directly · 0 of its ownK053440 Amplatzer Sizing Balloon IIAga Medical Corp. · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K053440Amplatzer Sizing Balloon IIAga Medical Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941269 | Gore Smoother II and Gore BPTB | W. L. Gore & Associates, Inc. | 1994 | — |
| −1 | K962765 | Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers)… | Cordis Corp. | 1997 | — |
| 0 (this device) | K993248 | Amplatzer Sizing Balloon | Aga Medical Corp. | 2000 | — |
| +1 | K053440 | Amplatzer Sizing Balloon II | Aga Medical Corp. | 2005 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (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 |
|---|---|---|---|
| * | K962765 | Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers) and (Wizdom…Summary page 2…keted balloon catheters used for temporary vessel occlusion. The intended use is equivalent to the Cordis Corporation STABILIZER Marker Wire and the WIZDOM Marker Wire (K962765). Safety and Performance: The following in vitro functional tests were performed on the AMPLATZER Sizing Balloon: e Calculation… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053440 | Amplatzer Sizing Balloon II | 2005 | 0 |
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 6 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K053440 (Aga Medical Corp., 2005) has gone furthest, with 0 descendants of its own.
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?
The AMPLATZER® Sizing Balloon 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993248 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993248: Amplatzer Sizing Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993248
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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