510(k) · Cleared
ClearedPta-Plus Pta Balloon Cather 5 MM X 4CM, Pta-Plus Pta Balloon Catheter 6MM X 4CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hotspur Technologies · DXE Catheter, Embolectomy
Cleared on Jul 12, 2010 as substantially equivalent to K901625 (Baxter Healthcare Corp, 1990) and 1 other predicate after a 109-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it.
- Decided
- Jul 12, 2010
- Review
- 109 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K014212 (2002). 3 ancestors in all, the oldest K901625 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK014212 Bard Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2002
- 1 generation backK073472 Vaccess Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
- This deviceK100842 Pta-Plus Pta Balloon Cather 5 MM X 4CM, Pta-Plus Pta Balloon…Hotspur Technologies · 2010
- Descendant · cites it directly · 1 of its ownK223613 InThrill Thrombectomy SystemInari Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK250421 InThrill™ Thrombectomy SystemInari Medical, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K014212 | Bard Conquest Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2002 | — |
| −1 | K073472 | Vaccess Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2008 | 1 |
| 0 (this device) | K100842 | Pta-Plus Pta Balloon Cather 5 MM X 4CM, Pta-Plus Pta Balloon Catheter 6MM X 4CM | Hotspur Technologies | 2010 | — |
| +1 | K223613 | InThrill Thrombectomy System | Inari Medical, Inc. | 2023 | — |
| +2 | K250421 | InThrill™ Thrombectomy System | Inari Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 DXE? 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 DXE device
- #1 K240078 Fogarty Thru-Lumen Embolectomy Catheterscore 7.9 · 1 generation · 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 |
|---|---|---|---|
| * | K901625 | Fogarty Arterial Embolectomy II CatheterSummary page 1…ctomy (21 CFR 870.5150, Product Code DXE) C. Predicate Device Name(s): Trade Name(s): Edwards Fogarty Adherent Clot Catheter, K901625 BARD Vaccess PTA Balloon Dilation Catheter, K073472 D. Device Descript… | 1990 |
| * | K073472 | Vaccess Pta Balloon Dilatation CatheterSummary page 1…Edwards Fogarty Adherent Clot Catheter, K901625 BARD Vaccess PTA Balloon Dilation Catheter, K073472 D. Device Description: The proposed PTA-Plus PTA Balloon Catheter is designed for de-clotting and treating stenosis… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223613 | InThrill Thrombectomy System | 2023 | 1 |
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 6.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K223613 (Inari Medical, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K901625.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DXE
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DXE
173in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXE
1in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DXE
306in 2025
MAUDE reports naming product code DXE, 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 | — | 3 | 167 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 0 | — | 5 | 124 |
| 2010 | 2 | — | 1 | 136 |
| 2011 | 0 | — | 1 | 164 |
| 2012 | 0 | — | 0 | 200 |
| 2013 | 0 | — | 0 | 150 |
| 2014 | 0 | — | 0 | 192 |
| 2015 | 1 | — | 13 | 266 |
| 2016 | 0 | — | 0 | 796 |
| 2017 | 2 | — | 0 | 770 |
| 2018 | 0 | — | 0 | 615 |
| 2019 | 0 | — | 0 | 594 |
| 2020 | 1 | — | 0 | 547 |
| 2021 | 1 | — | 4 (4) | 333 |
| 2022 | 1 | — | 3 | 463 |
| 2023 | 0 | — | 1 | 436 |
| 2024 | 5 | 173 | 0 | 377 |
| 2025 | 0 | — | 0 | 306 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The PTA-Plus PTA Balloon Catheter is indicated for use within synthetic arteriovenous dialysis fistulae to remove embolic material (thrombus/debris) and dilate stenosis for treatment of obstructive lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100842: Pta-Plus Pta Balloon Cather 5 MM X 4CM, Pta-Plus Pta Balloon Catheter 6MM X 4CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100842
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