Profoject Pen Needles (Model A; Model B)— 510(k) K260739
Substantially EquivalentCMT Health PTE., Ltd.
FDA 510(k) clearance K260739 for Profoject Pen Needles (Model A; Model B), Substantially Equivalent on 2026-07-15. Applicant: CMT Health PTE., Ltd.. Device class: 2.
Summary
CMT Health's Profoject Pen Needles come in Model A and Model B, filed under FMI, single lumen hypodermic needles. The record doesn't give gauges or say how the models differ.
Class II, 21 CFR 880.5570. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k).
CMT Health filed from Singapore. Review took 131 calendar days (March 6 to July 15, 2026).
Clearance details
- Applicant
- CMT Health PTE., Ltd.
- Product code
- Product code FMI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Recent devices under product code FMI
view all- K261266 — MOWANA Auto Duo
- K261719 — Promisemed X-Safety Pen Needle
- K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)
- K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)
- K261829 — Profoject Dual-Safety Pen Needles
More clearances from CMT Health PTE., Ltd.
view all- K262242 — Profoject Safe Push Button Blood Collection Sets
- K261372 — Profoject LOR Syringe
- K262215 — Profoject Safety Sliding Blood Collection Set
- K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
- K260855 — Profoject Safety Pen Needles
Adverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.