FDA applicant
Biobot Surgical Pte., Ltd.
FDA records 7 decisions for Biobot Surgical Pte., Ltd. (Singapore, SG) from 2011 to 2023: 7 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 153 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biobot Surgical Pte., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Biobot Surgical Pte., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report