510(k) · Cleared
ClearedSOLOPASS 2.0 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intravent Medical Partners · HAW Neurological Stereotaxic Instrument
Cleared on Sep 5, 2025 as substantially equivalent to K203251 (Intravent Medical Partners, LP, 2021) after a 129-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Sep 5, 2025
- Review
- 129 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K935595 (1995). 34 ancestors in all, the oldest K921148 (1992). No later device cites it as a predicate yet.
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations between
- 3 generations backK083597 Sonowand InviteSonowand AS · 2009
- 2 generations backK112469 General Prupose Localizers and Adapters-New Accessories for Sonowand…Sonowand AS · 2012
- 1 generation backK203251 SOLOPASS SystemIntravent Medical Partners, LP · 2021
- This deviceK251317 SOLOPASS 2.0 SystemIntravent Medical Partners · 2025
Show all 12 generations
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 10 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 9 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 8 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 6 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 5 generations backK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK072365 Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 3 generations backK083597 Sonowand InviteSonowand AS · 2009
- 2 generations backK112469 General Prupose Localizers and Adapters-New Accessories for Sonowand…Sonowand AS · 2012
- 1 generation backK203251 SOLOPASS SystemIntravent Medical Partners, LP · 2021
- This deviceK251317 SOLOPASS 2.0 SystemIntravent Medical Partners · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −11 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −10 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −9 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −8 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −6 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −5 | K063085 | Modification to Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −4 | K072365 | Sequoia Plus Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 3 |
| −3 | K083597 | Sonowand Invite | Sonowand AS | 2009 | — |
| −2 | K112469 | General Prupose Localizers and Adapters-New Accessories for Sonowand System | Sonowand AS | 2012 | — |
| −1 | K203251 | SOLOPASS System | Intravent Medical Partners, LP | 2021 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K203251 | SOLOPASS SystemSummary page 5…ry) HAW, 21 CFR 882.4560, Neurological Stereotaxic Instrument IYN, 21 CFR 892.1550, System, Imaging, Pulsed Doppler, Ultrasonic Predicate Device: SOLOPASS® System (K203251) Description of Device: The SOLOPASS® 2.0 System is the next generation product of the predicate device, SOLOPASS® System. The… | 2021 |
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 30 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 34 ancestors have a recall of any class.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 SOLOPASS 2.0 System is a tool that obtains ultrasound images and positional data to provide
intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251317: SOLOPASS 2.0 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251317
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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