510(k) · Cleared
ClearedIsr'obot Mona Lisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biobot Surgical Pte., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 7, 2013 as substantially equivalent to K111347 (Biobot Surgical Pte., Ltd., 2011) after a 64-day review. Its family tree reaches back 4 generations to 1988. 3 later devices descend from it.
- Decided
- Jun 7, 2013
- Review
- 64 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K875128 (1988). 7 ancestors in all, the oldest K864807 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK875128 Trans/R Needle GuideCIVCO Medical Instruments Co., Inc. · 1988
- 3 generations backK970514 Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle…CIVCO Medical Instruments Co., Inc. · 1997 · Recalled
- 2 generations backK041637 Targetscan Transrectal Ultrasound SystemEnvisioneering, LLC · 2004
- 1 generation backK111347 Isrobot Mona LisaBiobot Surgical Pte., Ltd. · 2011
- This deviceK130944 Isr'obot Mona LisaBiobot Surgical Pte., Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK203659 iSR'obot Mona Lisa 1.0Biobot Surgical Pte., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK213411 iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK232320 iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2023
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 |
|---|---|---|---|---|---|
| −4 | K875128 | Trans/R Needle Guide | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| −3 | K970514 | Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument… | CIVCO Medical Instruments Co., Inc. | 1997 | 3 |
| −2 | K041637 | Targetscan Transrectal Ultrasound System | Envisioneering, LLC | 2004 | — |
| −1 | K111347 | Isrobot Mona Lisa | Biobot Surgical Pte., Ltd. | 2011 | — |
| 0 (this device) | K130944 | Isr'obot Mona Lisa | Biobot Surgical Pte., Ltd. | 2013 | — |
| +1 | K203659 | iSR'obot Mona Lisa 1.0 | Biobot Surgical Pte., Ltd. | 2021 | — |
| +2 | K213411 | iSR’obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2021 | — |
| +3 | K232320 | iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K111347 | Isrobot Mona LisaSummary page 1…92.1560 Ultrasonic pulsed echo imaging system 892.1570 Diagnostic ultrasonic transducer Product Codes: IYO, ITX Panel: Radiology Predicate Device: iSR'obot Mona Lisa (K111347) pg. 10 iISR’obot Mona Lisa Special 510k Premarket Application Device Description: iSR'obot Mona Lisa is a plat… | 2011 |
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 |
|---|---|---|---|
| K203659 | iSR'obot Mona Lisa 1.0 | 2021 | 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 25 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K203659 (Biobot Surgical Pte., Ltd., 2021) has gone furthest, with 2 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. 2013, this device’s year, is highlighted.
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 | — |
What is it indicated for?
iSR’obot Mona Lisa is intended for use by a trained urologist or physician to perform the computer-assisted transperineal prostate biopsy under transrectal ultrasound guidance. The device serves as a biopsy needle guide only. It shall be used in conjunction with a third party ultrasound machine and endorectal probe that supports BMode, and a third party prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist.
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/K130944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130944: Isr'obot Mona Lisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130944
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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