510(k) · Cleared
ClearedA-View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stroke2prevent B.V. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on May 16, 2017 as substantially equivalent to K070515 (Cordatec N.V., 2007) after a 103-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- May 16, 2017
- Review
- 103 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K935595 (1995). 48 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 7 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 6 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 5 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 4 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 3 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 2 generations backK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 1 generation backK070515 A-View Basic and PlusCordatec N.V. · 2007
- This deviceK170338 A-ViewStroke2prevent B.V. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −7 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −6 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −5 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −4 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −3 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −2 | K052021 | V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −1 | K070515 | A-View Basic and Plus | Cordatec N.V. | 2007 | — |
| 0 (this device) | K170338 | A-View | Stroke2prevent B.V. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K070515 | A-View Basic and PlusSummary page 4…ucer Classification: ITX – Diagnostic Ultrasound Transducer, CFR 892.1570 Predicate Device: Cordatec n.v. – A-View® - K070515 Device Description: The A-View® is a catheter with an inflatable balloon that is inserted through an endotracheal tube of an ane… | 2007 |
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 22 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 48 ancestors have a recall of any class.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
A-View® is intended for use in conjunction with TEE investigation of the upper mediastinum in
anesthetized patients. They allow visibility of the distal ascending aorta by TEE and permit the condition of
the ascending aorta to be evaluated before surgery. A-View® is limited for use in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170338: A-View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170338
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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