510(k) · Cleared
ClearedGeneral Prupose Localizers and Adapters-New Accessories for Sonowand System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonowand AS · HAW Neurological Stereotaxic Instrument
Cleared on Mar 23, 2012 as substantially equivalent to K083597 (Sonowand AS, 2009) after a 210-day review. Its family tree reaches back 10 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 23, 2012
- Review
- 210 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K935595 (1995). 32 ancestors in all, the oldest K921148 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations between
- 3 generations backK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK072365 Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 1 generation backK083597 Sonowand InviteSonowand AS · 2009
- This deviceK112469 General Prupose Localizers and Adapters-New Accessories for Sonowand…Sonowand AS · 2012
- Descendant · cites it directly · 1 of its ownK203251 SOLOPASS SystemIntravent Medical Partners, LP · 2021
- Descendant · 2 generations on · 0 of its ownK251317 SOLOPASS 2.0 SystemIntravent Medical Partners · 2025
Show all 10 generations
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 8 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 7 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 6 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 4 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 3 generations backK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK072365 Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 1 generation backK083597 Sonowand InviteSonowand AS · 2009
- This deviceK112469 General Prupose Localizers and Adapters-New Accessories for Sonowand…Sonowand AS · 2012
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 |
|---|---|---|---|---|---|
| −10 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −9 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −8 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −7 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −6 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −4 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −3 | K063085 | Modification to Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −2 | K072365 | Sequoia Plus Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 3 |
| −1 | K083597 | Sonowand Invite | Sonowand AS | 2009 | — |
| 0 (this device) | K112469 | General Prupose Localizers and Adapters-New Accessories for Sonowand System | Sonowand AS | 2012 | — |
| +1 | K203251 | SOLOPASS System | Intravent Medical Partners, LP | 2021 | — |
| +2 | K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K083597 | Sonowand InviteSummary page 1…e general purpose localizers with adapters. These accessories are equivalent in function and intended use to the Navigator tool which was cleared in the original 510(k), K083597. Device Description: The 510(k) cleared SonoWand Invite System is a neuronavigation system with intraoperative imaging capabiliti… | 2009 |
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 |
|---|---|---|---|
| K203251 | SOLOPASS System | 2021 | 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 17 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 32 ancestors have a recall of any class.
- Of its descendants, K203251 (Intravent Medical Partners, LP, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K083597.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The Sonowand Invite System is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. It is also intended for use as a standard neuronavigation system and as a stand-alone ultrasound scanner.
The intended use of a localizer is to enable navigation by showing the position of surgical instruments or pointers relative to MR, CT or Ultrasound images
The General purpose localizers with adapters are intended to be used to attach surgical tools manufactured by other vendors. SonoWand Invite System will display position and orientation of the tools in the medical images on the screen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112469: General Prupose Localizers and Adapters-New Accessories for Sonowand System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112469
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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