510(k) · Cleared
ClearedSmartGuide Disposable Guides and Grids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
UC-CARE, Ltd. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jul 30, 2026 as substantially equivalent to K223689 (Advance Medical Designs, Inc., 2023) after a 191-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Jul 30, 2026
- Review
- 191 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K875128 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK875128 Trans/R Needle GuideCIVCO Medical Instruments Co., Inc. · 1988
- 2 generations backK970514 Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle…CIVCO Medical Instruments Co., Inc. · 1997 · Recalled
- 1 generation backK223689 Disposable Needle Guides and GridsAdvance Medical Designs, Inc. · 2023
- This deviceK260161 SmartGuide Disposable Guides and GridsUC-CARE, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K875128 | Trans/R Needle Guide | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| −2 | K970514 | Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument… | CIVCO Medical Instruments Co., Inc. | 1997 | 3 |
| −1 | K223689 | Disposable Needle Guides and Grids | Advance Medical Designs, Inc. | 2023 | — |
| 0 (this device) | K260161 | SmartGuide Disposable Guides and Grids | UC-CARE, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 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 |
|---|---|---|---|
| * | K223689 | Disposable Needle Guides and GridsSummary page 5…ode: ITX Regulatory Class: II 2. Identification of Predicate Device Name 510(k) Number Type Disposable Needle K223689 Primary Guides and Grids Disposable Guides K180970 Reference KDNG00… | 2023 |
| † | K180970 | Disposable guides KDNG00 | 2018 |
| † | K170741 | GTK Disposable Needle Guides | 2017 |
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 38 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 4 ancestors has 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. 2026, 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?
SmartGuide Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention by providing fixed guiding for the precise insertion of linear instruments, such as needles. The Needle Guides and Grids are designed to aid adult patient population, in need of a biopsy, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260161: SmartGuide Disposable Guides and Grids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260161
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026