Data / Medical devices / Singapore / Bioptimal International Pte. Ltd.
Bioptimal International Pte. Ltd.: FDA-registered device maker in SINGAPORE South East, Singapore, 14 510(k) clearances
Bioptimal International Pte. Ltd. is registered with the FDA (registration 8043983) in SINGAPORE South East, Singapore. It lists 8 device types. The FDA files 14 510(k) clearances under its listings, the newest dated May 28, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043983
- FEI number
- 3016261803
- Address
- 14 Kaki Bukit View, SINGAPORE South East, Singapore, 415950
- Owner or operator
- BIOPTIMAL INTERNATIONAL PTE LTD (9004883)
- Roles
- Manufacturer
- First device listed
- November 29, 2007
- Registered through
- 2026
- Brand names listed
- Accutrans¿ Disposable, Bioport System, Bioptimal Bipolar Pacing Catheter, Bioptimal Central Venous Catheter, Bioptimal Embolectomy Catheter, Bioptimal Pulmonary Artery Monitoring Catheter, Biotrans¿ Pressure Monitoring Kits, Biotrans¿ Reusable Sensor Base and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Embolectomy | DXE | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Flow Directed | DYG | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Retention Type, Balloon | EZL | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Pacemaker, Temporary | LDF | 2 | Manufacturer | accessdata.fda.gov |
| Probe, Thermodilution | KRB | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Blood-Pressure, Extravascular | DRS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 28, 2026 | K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N | DQO | Substantially Equivalent | Bioptimal International Pte. , Ltd. | accessdata.fda.gov |
| June 15, 2025 | K242863 | Bioptimal Bipolar Pacing Catheter | LDF | Substantially Equivalent | Bioptimal International Pte. , Ltd. | accessdata.fda.gov |
| November 6, 2019 | K182463 | Silicone Foley Catheter | EZL | Substantially Equivalent | Biosensors International Pte, Ltd. | accessdata.fda.gov |
| July 1, 2010 | K101669 | THERMODILUTION CATHETER | DQO | Substantially Equivalent | Biosensors Intl. Pte. , Ltd. | accessdata.fda.gov |
| January 5, 2010 | K083384 | THERMODILUTION CATHETER | DQO | Substantially Equivalent | Biosensors Intl. Pte. , Ltd. | accessdata.fda.gov |
| April 19, 2007 | K070710 | ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM | DRS | Substantially Equivalent | Biosensors International-USA | accessdata.fda.gov |
| March 12, 2003 | K022004 | CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 | DQO | Substantially Equivalent | Biosensors International-USA | accessdata.fda.gov |
| November 17, 2000 | K002786 | BIOSENSORS CENTRAL VENOUS CATHETER KITS | FOZ | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
| February 5, 1999 | K983372 | BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP | DRS | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
| September 4, 1998 | K973477 | BIOSENSORS EMBOLECTOMY CATHETER | DXE | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
| August 20, 1998 | K981747 | BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX | DRS | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
| July 17, 1998 | K981745 | BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX | DRS | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
| October 23, 1991 | K911710 | HEPARIN COATED THERMODILUTION CATH & ACCESSORIES | DQO | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
| September 27, 1991 | K912172 | SAFEWEDGE(TM) RELIEF VALVE DEVICE | KRB | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Blood-Pressure, Extravascular
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Electrode, Pacemaker, Temporary
- All makers of Catheter, Flow Directed
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Catheter, Retention Type, Balloon
Updated May 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.