510(k) · Cleared
ClearedTrans/V Needle Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CIVCO Medical Instruments Co., Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 15, 1988 after a 115-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- Apr 15, 1988
- Review
- 115 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 2 citing it directly.
- This deviceK875240 Trans/V Needle GuideCIVCO Medical Instruments Co., Inc. · 1988
- Descendant · cites it directly · 15 of its ownK970514 Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle…CIVCO Medical Instruments Co., Inc. · 1997 · Recalled
- Descendant · 2 generations on · 8 of its ownK041637 Targetscan Transrectal Ultrasound SystemEnvisioneering, LLC · 2004
- Descendant · 3 generations on · 4 of its ownK111347 Isrobot Mona LisaBiobot Surgical Pte., Ltd. · 2011
- Descendant · 4 generations on · 3 of its ownK130944 Isr'obot Mona LisaBiobot Surgical Pte., Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK222052 VitroPROCIVCO Medical Instruments Co., Inc. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K970514Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument GuideCIVCO Medical Instruments Co., Inc. · 1997 · cites it directly15descendants
- K041637Targetscan Transrectal Ultrasound SystemEnvisioneering, LLC · 2004 · 2 generations on8descendants
- K111347Isrobot Mona LisaBiobot Surgical Pte., Ltd. · 2011 · 3 generations on4descendants
- K130944Isr'obot Mona LisaBiobot Surgical Pte., Ltd. · 2013 · 4 generations on3descendants
- K222052VitroPROCIVCO Medical Instruments Co., Inc. · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K875240 | Trans/V Needle Guide | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| +1 | K970514 | Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument… | CIVCO Medical Instruments Co., Inc. | 1997 | 3 |
| +2 | K041637 | Targetscan Transrectal Ultrasound System | Envisioneering, LLC | 2004 | — |
| +3 | K111347 | Isrobot Mona Lisa | Biobot Surgical Pte., Ltd. | 2011 | — |
| +4 | K130944 | Isr'obot Mona Lisa | Biobot Surgical Pte., Ltd. | 2013 | — |
| +2 | K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 172 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K970514 (CIVCO Medical Instruments Co., Inc., 1997) has gone furthest, with 15 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
https://510kreport.com/device/K875240 · printed Nov 4, 2026
Cite this page
510(k) Report. “K875240: Trans/V Needle Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K875240
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026