510(k) · Cleared
ClearedEdwards Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences · OMZ Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Cleared on Jan 7, 2016 as substantially equivalent to K040830 (NuMED, Inc., 2004) after a 77-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Jan 7, 2016
- Review
- 77 days
- Class
- Class II
- Product code
- OMZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931009 (1993). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK931009 Tyshak Peripheral Balloon Dilation CatheterNuMED, Inc. · 1993 · Recalled
- 2 generations backK991977 Tyshak, Model 102 and Z-Med, Model 302NuMED, Inc. · 2000
- 1 generation backK040830 Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc. · 2004
- This deviceK153069 Edwards Balloon CatheterEdwards Lifesciences · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931009 | Tyshak Peripheral Balloon Dilation Catheter | NuMED, Inc. | 1993 | 1 |
| −2 | K991977 | Tyshak, Model 102 and Z-Med, Model 302 | NuMED, Inc. | 2000 | — |
| −1 | K040830 | Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters | NuMED, Inc. | 2004 | — |
| 0 (this device) | K153069 | Edwards Balloon Catheter | Edwards Lifesciences | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 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 OMZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K040830 | Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersSummary page 4…Pulmonary (Pulmonic) Valvuloplasty Catheter, 21 CFR 870.1250 Product Code: OMZ Predicate Device: NuMed Z-MED™ Balloon Dilatation Catheter (K040830) Device Description: The Edwards Balloon Catheter is used for balloon pulmonic valvuloplasty. The device consists of a nylon ba… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 20 ancestors have a recall of any class.
How does its category compare?
All OMZ devicesOMZ Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OMZ
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OMZ
Too few OMZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OMZ
No recall names OMZ since 2007.
Adverse event reports per year · OMZ
3in 2024
MAUDE reports naming product code OMZ, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Edwards Balloon Catheter is indicated for balloon pulmonic valvuloplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153069 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153069: Edwards Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153069
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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