510(k) · Cleared
Recalled · Class I · 2025Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Service and Savings, Inc. · OWQ Reprocessed Intravascular Ultrasound Catheter
Cleared on Sep 10, 2024 as substantially equivalent to K170263 (Siemens Medical Solutions USA, Inc., 2017) after a 263-day review. Its family tree reaches back 2 generations to 2007. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Sep 10, 2024
- Review
- 263 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071234 (2007). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK071234 Acunav Diagnostic Ultrasound Catheter 8F and 10FSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK170263 AcuNav Diagnostic Ultrasound Catheter 8F,10FSiemens Medical Solutions USA, Inc. · 2017
- This deviceK234064 Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound…Surgical Instrument Service and Savings, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10F | Siemens Medical Solutions USA, Inc. | 2007 | 1 |
| −1 | K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | Siemens Medical Solutions USA, Inc. | 2017 | — |
| 0 (this device) | K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for… | Surgical Instrument Service and Savings, Inc. | 2024 | — |
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.
1 device in this family has a Class I recall. 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 OWQ device
- #1 K254149 Reprocessed AcuNav CRYSTAL™ Ultrasound…score 13.4 · 7 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 |
|---|---|---|---|
| * | K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10FSummary page 6…Product Code OWQ Panel Cardiovascular The predicate models in K170263 include the subject Predicate device models of this submission. The predicate… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2025 | Class I | Z-1325-2026 | Under Investigation by firm | These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may… |
| Jul 31, 2025 | Class I | Z-2614-2025 | Under Investigation by firm | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 10.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K170263.
How does its category compare?
All OWQ devicesOWQ Reprocessed Intravascular Ultrasound Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OWQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWQ
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWQ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWQ
42in 2025
MAUDE reports naming product code OWQ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 3 | 261 | 0 | 9 |
| 2020 | 1 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 38 |
| 2022 | 2 | — | 0 | 24 |
| 2023 | 8 | 78 | 0 | 29 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 3 | 100 | 2 | 42 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Medline ReNewal Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
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/K234064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K234064: Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234064
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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