510(k) · Cleared
ClearedNeedle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide for 8824, Model UA 1337
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B-K Medical Aps · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Feb 2, 2009 as substantially equivalent to K043425 (Sheathing Technologies, Inc., 2005) after a 53-day review. Its family tree reaches back 2 generations to 1988. 3 later devices descend from it.
- Decided
- Feb 2, 2009
- Review
- 53 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K882383 (1988). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK882383 Maggi Series Ultra. Needle, Biopsy/Catheter GuidesCIVCO Medical Instruments Co., Inc. · 1988
- 1 generation backK043425 Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various…Sheathing Technologies, Inc. · 2005
- This deviceK083667 Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA…B-K Medical Aps · 2009
- Descendant · cites it directly · 2 of its ownK160806 Verza Guidance SystemCIVCO Medical Instruments Co., Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK262474 ND Needle Guidance SystemAccurate Access, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK250524 Mendaera Guidance SystemMendaera, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter Guides | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| −1 | K043425 | Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model… | Sheathing Technologies, Inc. | 2005 | — |
| 0 (this device) | K083667 | Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336… | B-K Medical Aps | 2009 | — |
| +1 | K160806 | Verza Guidance System | CIVCO Medical Instruments Co., Inc. | 2016 | — |
| +2 | K262474 | ND Needle Guidance System | Accurate Access, LLC | 2026 | — |
| +2 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K043425 | Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based…Summary page 1510(k) Summary continue FEB 2 2009 Biopsy guides in this K043425 submission Intended Use Needle Guide for BK Medical The Needle G… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160806 | Verza Guidance System | 2016 | 2 |
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 21 years and passes through 3 companies; a new generation was cleared every 16.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K160806 (CIVCO Medical Instruments Co., Inc., 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Needle guide(s): provides guidance for-needles or other :interventidnal:devices during an ultrasound-guideda'proced'ure. It positions the needle relative to the:transducer, so that the needle image is :ina specified position in the ultrasound image during procedcures. that require precise needle placement or biopsy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083667 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083667: Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide for 8824, Model UA 1337.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083667
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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