Biobot Surgical Pte., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Biobot Surgical Pte., Ltd.” (first 2011, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 140 days. Since 2017 the median was 146 days, against 127 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 64 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 169 |
| 2017 | 1 | 153 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 134 |
| 2022 | 0 | — |
| 2023 | 1 | 140 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biobot Surgical Pte., Ltd. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 5 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (7)
Most recent Biobot Surgical Pte., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232320 | iSR`obot Mona Lisa 2.0 | IYO | 2023-12-21 | 140 |
| K213411 | iSRobot Mona Lisa 2.0 | IYO | 2021-12-22 | 64 |
| K203659 | iSR'obot Mona Lisa 1.0 | IYO | 2021-07-08 | 205 |
| K163502 | iSR'obot Biopsy Kit | ITX | 2017-05-16 | 153 |
| K161109 | iSR'obot MRI-US Fusion | LLZ | 2016-10-06 | 169 |
| K130944 | ISR'OBOT MONA LISA | IYO | 2013-06-07 | 64 |
| K111347 | ISROBOT MONA LISA | IYO | 2011-08-12 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Biobot Surgical Pte., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biobot Surgical Pte., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Biobot Surgical Pte., Ltd.” (first 2011, latest 2023), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biobot Surgical Pte., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biobot Surgical Pte., Ltd. is 140 days. Since 2017: 146 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biobot Surgical Pte., Ltd.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 5); ITX (Transducer, Ultrasonic, Diagnostic, 1); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 7 Biobot Surgical Pte., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Biobot Surgical Pte., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.