CMT Health PTE., Ltd. · Class II · Cleared Oct 16, 2025
| K-number | K252631 |
| Device name | Profoject Disposable Needle |
| Applicant | CMT Health PTE., Ltd. |
| Product code | FMI |
| Device class | Class II |
| Decision date | Oct 16, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.5570 |
The Profoject™ Disposable Needle is a single-use hypodermic needle consisting of a stainless steel needle tube, polypropylene hub with Luer connector, and polypropylene cap. It is intended for general purpose fluid injection and aspiration when used with Luer lock or Luer slip syringes and injection devices in hospitals and clinics.
The proposed device differs from the predicate in needle gauge (adds 16G and 24G options) and needle length (adds shorter 10mm and 13mm options), but both use identical materials (stainless steel tube, polypropylene hub and cap), single-use design, EO sterilization at SAL 10⁻⁶, ISO 6009 color coding, and Luer connectors. The proposed device underwent additional biocompatibility tests (intracutaneous reactivity, acute systemic toxicity, hemolysis, complement activation, and PTT) beyond the predicate's scope.
ISO 7864:2016 (sterile hypodermic needles), ISO 9626:2016 (stainless steel needle tubing), ISO 80369-7:2021 (Luer connectors), ISO 10993-1:2018 (biocompatibility), ISO 11135:2014 (EO sterilization), USP <788> (particulate matter), ASTM F88/F88M-23 (seal strength), and ASTM F1929-23 (dye penetration).
View the full FDA submission: accessdata.fda.gov