510(k) · Cleared
Recalled · Class II · 2018Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CIVCO Medical Instruments Co., Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jun 20, 1997 as substantially equivalent to K875128 (CIVCO Medical Instruments Co., Inc., 1988) and 1 other predicate after a 129-day review. Its family tree reaches back 1 generation to 1988. 15 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 20, 1997
- Review
- 129 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K875128 (1988). 2 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK875128 Trans/R Needle GuideCIVCO Medical Instruments Co., Inc. · 1988
- This deviceK970514 Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle…CIVCO Medical Instruments Co., Inc. · 1997
- Descendant · cites it directly · 8 of its ownK041637 Targetscan Transrectal Ultrasound SystemEnvisioneering, LLC · 2004
- Descendant · 2 generations on · 4 of its ownK111347 Isrobot Mona LisaBiobot Surgical Pte., Ltd. · 2011
- Descendant · 3 generations on · 3 of its ownK130944 Isr'obot Mona LisaBiobot Surgical Pte., Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK222052 VitroPROCIVCO Medical Instruments Co., Inc. · 2022
- Descendant · 4 generations on · 2 of its ownK203659 iSR'obot Mona Lisa 1.0Biobot Surgical Pte., Ltd. · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K041637Targetscan Transrectal Ultrasound SystemEnvisioneering, LLC · 2004 · cites it directly8descendants
- K111347Isrobot Mona LisaBiobot Surgical Pte., Ltd. · 2011 · 2 generations on4descendants
- K130944Isr'obot Mona LisaBiobot Surgical Pte., Ltd. · 2013 · 3 generations on3descendants
- K222052VitroPROCIVCO Medical Instruments Co., Inc. · 2022 · cites it directly2descendants
- K203659iSR'obot Mona Lisa 1.0Biobot Surgical Pte., Ltd. · 2021 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K875128 | Trans/R Needle Guide | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| 0 (this device) | K970514 | Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument… | CIVCO Medical Instruments Co., Inc. | 1997 | — |
| +1 | K041637 | Targetscan Transrectal Ultrasound System | Envisioneering, LLC | 2004 | — |
| +2 | K111347 | Isrobot Mona Lisa | Biobot Surgical Pte., Ltd. | 2011 | — |
| +3 | K130944 | Isr'obot Mona Lisa | Biobot Surgical Pte., Ltd. | 2013 | — |
| +1 | K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2022 | — |
| +4 | K203659 | iSR'obot Mona Lisa 1.0 | Biobot Surgical Pte., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K875128 | Trans/R Needle GuideSummary page 1…IVCO Disposable Endocavity Ultrasound Needle / Biopsy Guide is equivalent to CIVCO's currently, legally marketed Transrectal Needle/Biopsy Guide, 510(k) reference number K875128/A, and Transvaginal Needle/Biopsy Guide, 510(k) reference number K875240/A. Description of Subject Device Submitted for Premarke… | 1988 |
| * | K875240 | Trans/V Needle GuideSummary page 1…to CIVCO's currently, legally marketed Transrectal Needle/Biopsy Guide, 510(k) reference number K875128/A, and Transvaginal Needle/Biopsy Guide, 510(k) reference number K875240/A. Description of Subject Device Submitted for Premarket Notification: - The subject device provides a fixed path by which to al… | 1988 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2018 | Class II | Z-2946-2018 | Process control | The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide. |
| Jul 30, 2018 | Class II | Z-2947-2018 | Process control | The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide. |
| Jan 16, 2008 | Not classified | Z-1054-2008 | Packaging | Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054). |
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?
Diagnostic ultrasound needle / instrument guided procedures - transvaginal and transrectal: tissue biopsy, fluid aspiration, catheter placement, and treatment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970514 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970514: Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970514
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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