510(k) · Cleared
ClearedVu-Path Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crystalline Medical · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 25, 2021 as substantially equivalent to K142443 (C.R. Bard, Inc., 2014) after a 192-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Jun 25, 2021
- Review
- 192 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K850478 (1985). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK850478 PLUS 1Dymax Corp · 1985
- 5 generations backK993624 Site-Rite 3 Ultrasound SystemDymax Corp · 1999
- 4 generations backK032135 Site-Rite IV Ultrasound SystemDymax Corp · 2003
- 3 generations backK052517 Site-Rite 5 Ultrasound SystemC.R. Bard, Inc. · 2005
- 2 generations backK071204 Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007
- 1 generation backK142443 Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2014
- This deviceK203657 Vu-Path Ultrasound SystemCrystalline Medical · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K850478 | PLUS 1 | Dymax Corp | 1985 | — |
| −5 | K993624 | Site-Rite 3 Ultrasound System | Dymax Corp | 1999 | — |
| −4 | K032135 | Site-Rite IV Ultrasound System | Dymax Corp | 2003 | — |
| −3 | K052517 | Site-Rite 5 Ultrasound System | C.R. Bard, Inc. | 2005 | — |
| −2 | K071204 | Site-Rite 6 Ultrasound System, Model Site-Rite 6 | C.R. Bard, Inc. | 2007 | — |
| −1 | K142443 | Site-Rite 6 Ultrasound System with Pinpoint GT Technology | C.R. Bard, Inc. | 2014 | — |
| 0 (this device) | K203657 | Vu-Path Ultrasound System | Crystalline Medical | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K142443 | Site-Rite 6 Ultrasound System with Pinpoint GT TechnologySummary page 4….1560 and 892.1570 (IYN, IYO, ITX) Classification Panel: Radiology A. Legally Marketed Predicate Devices The predicate device is the Site~Rite 6 Ultrasound System (K142443) Manufactured by C.R. Bard, Inc. B. Device Description and List Of Device Components and Accessories: The Vu-Path Ultrasound Sys… | 2014 |
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 36 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K142443.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The Vu-Path Ultrasound System with associated probe and accessories provide ultrasound guidance for the placement of needles and catheters in vascular structures adults aged 22 and older. Ultrasound imaging of vascular structures and surrounding tissue may also be performed. The ultrasound probe is only intended to be placed on the surface of the skin and should not be advanced percutaneously. The device provides B-Mode and Color Doppler modes of operation.
The Vu-Path Ultrasound system needle guidance technology is indicated for use by appropriately-trained healthcare professionals to provide them with visual tools for passive tracking of a needle with respect to ultrasound image data.
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/K203657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203657: Vu-Path Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203657
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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