510(k) · Cleared
ClearedSheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based on Transducer and Cover)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheathing Technologies, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Feb 28, 2005 as substantially equivalent to K931403 (Dymax Corp, 1993) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1988. 4 later devices descend from it.
- Decided
- Feb 28, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K882383 (1988). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK882383 Maggi Series Ultra. Needle, Biopsy/Catheter GuidesCIVCO Medical Instruments Co., Inc. · 1988
- This deviceK043425 Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various…Sheathing Technologies, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK083667 Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA…B-K Medical Aps · 2009
- Descendant · 2 generations on · 2 of its ownK160806 Verza Guidance SystemCIVCO Medical Instruments Co., Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK262474 ND Needle Guidance SystemAccurate Access, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK250524 Mendaera Guidance SystemMendaera, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K083667Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide…B-K Medical Aps · 2009 · cites it directly3descendants
- K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc. · 2016 · 2 generations on2descendants
- K262474ND Needle Guidance SystemAccurate Access, LLC · 2026 · 3 generations on0descendants
- K250524Mendaera Guidance SystemMendaera, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter Guides | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| 0 (this device) | K043425 | Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model… | Sheathing Technologies, Inc. | 2005 | — |
| +1 | K083667 | Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336… | B-K Medical Aps | 2009 | — |
| +2 | K160806 | Verza Guidance System | CIVCO Medical Instruments Co., Inc. | 2016 | — |
| +3 | K262474 | ND Needle Guidance System | Accurate Access, LLC | 2026 | — |
| +3 | K250524 | Mendaera Guidance System | Mendaera, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (2)
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.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083667 | Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide… | 2009 | 3 |
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?
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Sheathes Needle Guide provides guidance for a needle, catheter, biopsy apparatus, or other interventional device by positioning it relative to the ultrasound transducer and the resulting image during a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043425: Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based on Transducer and Cover).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043425
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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