510(k) · Cleared
ClearedReprocessed Diagnostic Ultrasound Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · OWQ Reprocessed Intravascular Ultrasound Catheter
Cleared on Mar 10, 2016 as substantially equivalent to K071234 (Siemens Medical Solutions USA, Inc., 2007) after a 136-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it.
- Decided
- Mar 10, 2016
- Review
- 136 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071234 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK071234 Acunav Diagnostic Ultrasound Catheter 8F and 10FSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK153090 Reprocessed Diagnostic Ultrasound CatheterInnovative Health, LLC · 2016
- Descendant · cites it directly · 0 of its ownK163560 Reprocessed AcuNav Diagnostic Ultrasound CatheterInnovative Health, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K163560Reprocessed AcuNav Diagnostic Ultrasound CatheterInnovative Health, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10F | Siemens Medical Solutions USA, Inc. | 2007 | 1 |
| 0 (this device) | K153090 | Reprocessed Diagnostic Ultrasound Catheter | Innovative Health, LLC | 2016 | — |
| +1 | K163560 | Reprocessed AcuNav Diagnostic Ultrasound Catheter | Innovative Health, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 OWQ? 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 |
|---|---|---|---|
| * | K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10FSummary page 5…Class II, 21 CFR 870.1200 Product Code: OWQ Predicate Device: 510(k) Number 510(k) Title Manufacturer K071234 AcuNav Diagnostic Ultrasound Catheter Siemens Medical 8F and 10F… | 2007 |
| † | K063076 | Reprocessed Diagnostic Ultrasound Catheter | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163560 | Reprocessed AcuNav Diagnostic Ultrasound Catheter | 2017 | 0 |
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?
How does its category compare?
All OWQ devicesOWQ Reprocessed Intravascular Ultrasound Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Reprocessed Acunav Diagnostic Ultrasound Catheter is intended for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.
The reprocessed device is not indicated for use with pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153090: Reprocessed Diagnostic Ultrasound Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153090
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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