CMT Health PTE., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “CMT Health PTE., Ltd.” (first 2025, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 100 days. Since 2017 the median was 100 days, against 168 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 |
|---|---|---|
| 2025 | 3 | 56 |
| 2026 | 7 | 131 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name CMT Health PTE., Ltd. took a median 100 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 168 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 4 | 4 |
| FMF | Syringe, Piston | 3 | 3 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 2 | 2 |
| QNQ | Low Dead Space Piston Syringe | 1 | 1 |
Review panels
Most recent CMT Health PTE., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261829 | Profoject Dual-Safety Pen Needles | FMI | 2026-07-29 | 57 |
| K260739 | Profoject Pen Needles (Model A; Model B) | FMI | 2026-07-15 | 131 |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle | FMF | 2026-06-12 | 115 |
| K260855 | Profoject Safety Pen Needles | FMI | 2026-06-10 | 86 |
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap | PNR | 2026-04-08 | 191 |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe | FMF | 2026-02-23 | 154 |
| K252814 | Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe | QNQ | 2026-02-19 | 168 |
| K252631 | Profoject Disposable Needle | FMI | 2025-10-16 | 57 |
| K252033 | Profoject Disposable Syringe, Profoject Disposable Syringe with Needle | FMF | 2025-07-25 | 25 |
| K251585 | Profoject Enteral Feeding Syringe | PNR | 2025-07-18 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named CMT Health 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 CMT Health PTE., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “CMT Health PTE., Ltd.” (first 2025, latest 2026), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by CMT Health PTE., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name CMT Health PTE., Ltd. is 100 days. Since 2017: 100 days, versus 168 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under CMT Health PTE., Ltd.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 4); FMF (Syringe, Piston, 3); PNR (Enteral Syringes With Enteral Specific Connectors, 2).
Next steps
- See all 10 CMT Health PTE., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMI, CMT Health 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.