510(k) · Cleared
ClearedPark Blade Septostomy Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DXF Catheter, Septostomy
Cleared on Apr 4, 2019 as substantially equivalent to K801031 (Cook, Inc., 1980) after a 212-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Apr 4, 2019
- Review
- 212 days
- Class
- Class II
- Product code
- DXF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K801031 (1980). No later device cites it as a predicate yet.
- Root · 1 generation backK801031 Blade Septostomy CatheterCook, Inc. · 1980
- This deviceK182399 Park Blade Septostomy CatheterCook Incorporated · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801031 | Blade Septostomy Catheter | Cook, Inc. | 1980 | — |
| 0 (this device) | K182399 | Park Blade Septostomy Catheter | Cook Incorporated | 2019 | — |
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 DXF? 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 DXF device
- #1 K242076 VersaCross™ RF Wirescore 14.9 · 3 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 |
|---|---|---|---|
| * | K801031 | Blade Septostomy CatheterSummary page 4…ction with a transseptal technique. Predicate Device: The predicate device, the Blade Septostomy Catheter, was cleared for commercial distribution under 510(k) number K801031, on July 28, 1980. Comparison to Predicate Device: It has been demonstrated that the Park Blade Septostomy Catheter is identi… | 1980 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DXF devicesDXF Catheter, Septostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DXF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXF
83in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXF
3in 2020
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DXF
682in 2025
MAUDE reports naming product code DXF, 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 | 2 |
| 2008 | 1 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 0 | — | 1 | 13 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 36 |
| 2019 | 1 | — | 0 | 24 |
| 2020 | 0 | — | 3 (3) | 55 |
| 2021 | 1 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 70 |
| 2023 | 1 | — | 0 | 286 |
| 2024 | 4 | 83 | 0 | 368 |
| 2025 | 2 | — | 0 | 682 |
| 2026 | 3 | 30 | 0 | — |
What is it indicated for?
The Park Blade Septostomy Catheter is intended to enlarge interatrial openings. The device can also be used when balloon atrial septostomy is insufficient or unsuccessful, particularly in older infants and children with a thickened atrial septum. Normally, the existing interatrial opening is used for this procedure. However, if the interatrial septum is intact, the procedure can be performed in conjunction with a transseptal technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182399 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182399: Park Blade Septostomy Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182399
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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