# CMT Health PTE., Ltd.

- Location (FDA's records): Singapore, SG
- FDA decisions: 12 (2025–2026): 12 510(k) clearances
- Product codes: FMI (4), FMF (3), PNR (2), QNQ (1), JKA (1), CAZ (1)
- 510(k) review time since 2016: median 87 days, against 130 for FDA's reviews in the same codes and years (7 of 8 faster)
- Predicates its devices cite: 17 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sol-Millennium Medical, Inc.: 2 (https://510kreport.com/company/sol-millennium-medical)
- Azur Medical Company, Inc.: 2 (https://510kreport.com/company/azur-medical)
- Neomed, Inc.: 2 (https://510kreport.com/company/neomed)
- Medexel Co.,Ltd: 1 (https://510kreport.com/company/medexel)
- Promisemed Hangzhou Meditech Co., Ltd.: 1 (https://510kreport.com/company/promisemed-hangzhou-meditech)
- Tyco Healthcare: 1 (https://510kreport.com/company/tyco-healthcare)
- Cedic S.R.L.: 1 (https://510kreport.com/company/cedic)
- Ningbo Tianyi Medical Appliance Co., Ltd.: 1 (https://510kreport.com/company/ningbo-tianyi-medical-appliance)

## Recent decisions
- K262215: Profoject™ Safety Sliding Blood Collection Set (Sep 25, 2026)
- K261372: Profoject™ LOR Syringe (Sep 25, 2026)
- K261829: Profoject™ Dual-Safety Pen Needles (Jul 29, 2026)
- K260739: Profoject™ Pen Needles (Model A; Model B) (Jul 15, 2026)
- K260514: Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle (Jun 12, 2026)
- K260855: Profoject™ Safety Pen Needles (Jun 10, 2026)
- K253268: Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap (Apr 8, 2026)
- K253068: Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (Feb 23, 2026)

Source page: https://510kreport.com/company/cmt-health