510(k) · Cleared
ClearedND Needle Guidance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accurate Access, LLC · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jul 27, 2026 as substantially equivalent to K160806 (CIVCO Medical Instruments Co., Inc., 2016) and 1 other predicate after a 10-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Jul 27, 2026
- Review
- 10 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K850478 (1985). 13 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 backK093713 Ultrasound General Purpose Guidance SystemCivco Medical Instruments · 2010 · Recalled
- This deviceK262474 ND Needle Guidance SystemAccurate Access, LLC · 2026
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 | K093713 | Ultrasound General Purpose Guidance System | Civco Medical Instruments | 2010 | 7 |
| 0 (this device) | K262474 | ND Needle Guidance System | Accurate Access, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160806 | Verza Guidance SystemSummary page 5…c Transducer Product Code ITX Regulation Number 892.1570 Regulatory Class Class II PREDICATE DEVICES K160806 CIVCO Medical Instruments Verza Guidance System K093713 CIVCO Medical Instruments AccuSITE Needle Guides IN… | 2016 |
| * | K093713 | Ultrasound General Purpose Guidance SystemSummary page 5…Number 892.1570 Regulatory Class Class II PREDICATE DEVICES K160806 CIVCO Medical Instruments Verza Guidance System K093713 CIVCO Medical Instruments AccuSITE Needle Guides INDICATIONS for USE The ND® Needle Guidance System is indicated for u… | 2010 |
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 41 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K160806.
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?
The ND® Needle Guidance System is indicated for use in ultrasound-guided procedures where precise placement of common interventional devices is required, such as for vascular access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262474: ND Needle Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262474
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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