Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CMT Health PTE., Ltd. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
191 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261829 | Profoject™ Dual-Safety Pen Needles | CMT Health PTE., Ltd. | 2026-07-29 | 57 | 0 |
| K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | 2026-07-15 | 131 | 0 |
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Nee | CMT Health PTE., Ltd. | 2026-06-12 | 115 | 0 |
| K260855 | Profoject™ Safety Pen Needles | CMT Health PTE., Ltd. | 2026-06-10 | 86 | 0 |
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable E | CMT Health PTE., Ltd. | 2026-04-08 | 191 | 0 |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable | CMT Health PTE., Ltd. | 2026-02-23 | 154 | 0 |
| K252814 | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syr | CMT Health PTE., Ltd. | 2026-02-19 | 168 | 0 |
| K252631 | Profoject™ Disposable Needle | CMT Health PTE., Ltd. | 2025-10-16 | 57 | 0 |
| K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe | CMT Health PTE., Ltd. | 2025-07-25 | 25 | 0 |
| K251585 | Profoject™ Enteral Feeding Syringe | CMT Health PTE., Ltd. | 2025-07-18 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda