# FDA device clearances in Singapore: 38 since Nov 2024

Updated October 28, 2026.

FDA made 38 device decisions for applicants in Singapore from December 19, 2024 to October 28, 2026: 38 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 16 applicants. The newest, K262242 on October 28, 2026, is Profoject™ Safe Push Button Blood Collection Sets from CMT Health PTE., Ltd..

## The full list

FDA device clearances for applicants in Singapore: 38 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 2 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email.

Buy: https://specstream.ai/data/fda-clearances/country/singapore

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 38
- 510(k) and De Novo: 38
- PMA: 0
- Latest decision: October 28, 2026

## Newest decisions

The newest 38 of 38, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 28, 2026 | K262242 | Profoject™ Safe Push Button Blood Collection Sets | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262242) |
| October 16, 2026 | K262478 | BCS Bioceramic Sealer | BCS Device Pte., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | KIF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262478) |
| September 25, 2026 | K262215 | Profoject™ Safety Sliding Blood Collection Set | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262215) |
| September 25, 2026 | K261372 | Profoject™ LOR Syringe | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | CAZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261372) |
| September 25, 2026 | K260140 | Aevice Wheeze Detection Module | Aevice Health Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | PHZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260140) |
| August 27, 2026 | K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) | Ram.Shaw Pte., Ltd. | Singapore | Substantially Equivalent | 510(k) special | LRK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262104) |
| July 29, 2026 | K261829 | Profoject™ Dual-Safety Pen Needles | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261829) |
| July 15, 2026 | K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260739) |
| June 12, 2026 | K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with... | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260514) |
| June 12, 2026 | K252987 | ADRx™ Admixture Device | Epic Medical Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | LHI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252987) |
| June 10, 2026 | K260855 | Profoject™ Safety Pen Needles | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260855) |
| May 28, 2026 | K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF... | Bioptimal International Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | DQO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252702) |
| April 24, 2026 | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | MEB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250234) |
| April 8, 2026 | K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B)... | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | PNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253268) |
| March 3, 2026 | K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | LRK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253845) |
| February 23, 2026 | K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253068) |
| February 19, 2026 | K252814 | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with... | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | QNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252814) |
| December 5, 2025 | K251722 | ProSeal™ Transfer Injector (421120, 421130, 421140) | Epic Medical Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) special | ONB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251722) |
| November 25, 2025 | K252161 | Hushd Avera | Good Sleep CO Pte , Ltd. | Singapore | Substantially Equivalent | 510(k) abbreviated | LRK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252161) |
| October 24, 2025 | K251784 | Hushd Pro Z-Link | Good Sleep CO Pte , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | LRK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251784) |
| October 16, 2025 | K252631 | Profoject™ Disposable Needle | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252631) |
| September 4, 2025 | K251656 | Careverse CoronaryDoc (Careverse CoronaryDoc) | Careverse Technology Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251656) |
| August 29, 2025 | K251814 | EZ™ IV Administration Set | Epic Medical Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251814) |
| August 5, 2025 | K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | BZQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250934) |
| August 5, 2025 | K244016 | iPETcertum (v1.0) | Claritas Healthtech Pte, Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244016) |
| August 1, 2025 | K252094 | eZSURE™ Empty Fluid Container | Epic Medical Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) special | KPE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252094) |
| July 25, 2025 | K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252033) |
| July 18, 2025 | K251585 | Profoject™ Enteral Feeding Syringe | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | PNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251585) |
| June 20, 2025 | K250151 | Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.Ai | Singapore | Substantially Equivalent | 510(k) traditional | SDJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250151) |
| June 15, 2025 | K242863 | Bioptimal Bipolar Pacing Catheter | Bioptimal International Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | LDF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242863) |
| May 29, 2025 | K251340 | ProSeal™ Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) special | ONB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251340) |
| May 5, 2025 | K243603 | AeviceMD | Aevice Health Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | DSH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243603) |
| May 2, 2025 | K243894 | F88 URE-SD/RD Flexible Ureteroscope | Sg Endoscopy Pte, Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243894) |
| March 17, 2025 | K241975 | SERV MEDICAL CDSS | Serv Medical Pte., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241975) |
| February 3, 2025 | K243268 | TipTraQ (TTQ001) | Pranaq Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243268) |
| January 22, 2025 | K243976 | ZeroClear™ Bag Access (423100) | Epic Medical Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) special | ONB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243976) |
| December 26, 2024 | K240517 | ProSeal™ Vented Universal Vial Adaptor | Epic Medical Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | ONB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240517) |
| December 19, 2024 | K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) abbreviated | IPF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240348) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| CMT Health PTE., Ltd. | 13 | October 28, 2026 |
| Epic Medical Pte. , Ltd. | 8 | June 12, 2026 |
| Aevice Health Pte. , Ltd. | 2 | September 25, 2026 |
| Bioptimal International Pte. , Ltd. | 2 | May 28, 2026 |
| Good Sleep CO Pte , Ltd. | 2 | November 25, 2025 |
| BCS Device Pte., Ltd. | 1 | October 16, 2026 |
| Ram.Shaw Pte., Ltd. | 1 | August 27, 2026 |
| Ram.Shaw Pte. , Ltd. | 1 | March 3, 2026 |
| Careverse Technology Pte. , Ltd. | 1 | September 4, 2025 |
| Respiree Pte, Ltd. | 1 | August 5, 2025 |
| Claritas Healthtech Pte, Ltd. | 1 | August 5, 2025 |
| Eko.Ai Pte Ltd. D/B/A Us2.Ai | 1 | June 20, 2025 |
| Sg Endoscopy Pte, Ltd. | 1 | May 2, 2025 |
| Serv Medical Pte., Ltd. | 1 | March 17, 2025 |
| Pranaq Pte. , Ltd. | 1 | February 3, 2025 |
| Quantumtx Pte. , Ltd. | 1 | December 19, 2024 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 16 | July 29, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 5 | October 16, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 4 | September 25, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 4 | May 28, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 3 | April 8, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 3 | September 4, 2025 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 2 | October 28, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 1 | December 19, 2024 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 31 | October 28, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 5 | August 27, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 2 | November 25, 2025 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).