510(k) · Cleared
ClearedPrecision Point Biopsy Needle Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corbin Clinical Resources, LLC · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Aug 1, 2016 as substantially equivalent to K030064 (Sonosite,Inc., 2003) after a 167-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Aug 1, 2016
- Review
- 167 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030064 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK030064 Ilook 25 Needle Guide Attachment and Bracket AssemblySonosite,Inc. · 2003 · Recalled
- This deviceK160414 Precision Point Biopsy Needle GuideCorbin Clinical Resources, LLC · 2016
- Descendant · cites it directly · 0 of its ownK233109 TP Pivot Pro™ Needle GuideCivco Medical Solutions · 2023
Most influential descendants
Showing 1 of 1 · See all- K233109TP Pivot Pro™ Needle GuideCivco Medical Solutions · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030064 | Ilook 25 Needle Guide Attachment and Bracket Assembly | Sonosite,Inc. | 2003 | 16 |
| 0 (this device) | K160414 | Precision Point Biopsy Needle Guide | Corbin Clinical Resources, LLC | 2016 | — |
| +1 | K233109 | TP Pivot Pro™ Needle Guide | Civco Medical Solutions | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K030064 | Ilook 25 Needle Guide Attachment and Bracket AssemblySummary page 5…re-amendment devices: Sonosite iLook 25 Needle Guide Attachment and Bracket Assembly; Class II medical devices that were cleared for marketing in the United States under K030064. K160414 510(k) Summary PrecisionPoint Biopsy Needle Guide Page 3 of 3… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233109 | TP Pivot Pro™ Needle Guide | 2023 | 0 |
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. 2016, 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 intended use of the Perineologic PrecisionPoint™ Biopsy Needle Guide when used in conjunction with a BK ProFocus 2202 ultrasound system and attached to the ultrasound system's transrectal transducer, is to facilitate proper needle placement to access anatomical structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160414: Precision Point Biopsy Needle Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160414
Report an extraction error
Are you the manufacturer?
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