510(k) · Cleared
ClearedBASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thrombolex, Inc. · QEY Mechanical Thrombolysis Catheter
Cleared on Jul 3, 2023 as substantially equivalent to K222095 (Thrombolex, Inc., 2023) after a 27-day review. Its family tree reaches back 6 generations to 2014.
- Decided
- Jul 3, 2023
- Review
- 27 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K140151 (2014). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK140151 Ekosonic Mach 4 Endovascular Device/Ekosonic Control UnitBtg International, Inc. · 2014 · Recalled
- 5 generations backK162771 EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. · 2017 · Recalled
- 4 generations backK183361 EkoSonic Endovascular Device with Control Unit 4.0Btg International, Inc. · 2019 · Recalled
- 3 generations backK191119 EkoSonic Endovascular DeviceBtg International, Inc. · 2019
- 2 generations backK211080 EkoSonic Endovascular DeviceBoston Scientific · 2021
- 1 generation backK222095 BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular…Thrombolex, Inc. · 2023
- This deviceK231653 BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular…Thrombolex, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K140151 | Ekosonic Mach 4 Endovascular Device/Ekosonic Control Unit | Btg International, Inc. | 2014 | 3 |
| −5 | K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Btg International, Inc. | 2017 | 1 |
| −4 | K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | 2019 | 2 |
| −3 | K191119 | EkoSonic Endovascular Device | Btg International, Inc. | 2019 | — |
| −2 | K211080 | EkoSonic Endovascular Device | Boston Scientific | 2021 | — |
| −1 | K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter… | Thrombolex, Inc. | 2023 | — |
| 0 (this device) | K231653 | BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter | Thrombolex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 QEY? 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 QEY device
- #1 K241851 Versus™ Catheter (VS110-8B)score 16.8 · 19 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 |
|---|---|---|---|
| * | K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.…Summary page 4…QEY, KRA Panel: Cardiovascular 3. PREDICATE DEVICE BASHIR™ Endovascular Catheter, BASHIR™ S-B Endovascular Catheter, K222095 4. DESCRIPTION OF THE DEVICE The BASHIR™ .035 Endovascular Catheter is a device intended for mechanical thrombolysis via expa… | 2023 |
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 9 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 7 ancestors have a recall of any class.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QEY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QEY
62in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEY
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEY
5in 2025
MAUDE reports naming product code QEY, 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 | 5 | 28 | 0 | 0 |
| 2008 | 4 | 54 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | 144 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 5 | 91 | 0 | 0 |
| 2020 | 3 | 158 | 0 | 0 |
| 2021 | 3 | 62 | 0 | 0 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 2 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular Catheter are mechanical thrombolysis catheters indicated for the:
• Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries for treatment of pulmonary embolism.
• Infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231653 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231653: BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231653
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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