Profoject Safety Pen Needles— 510(k) K260855
Substantially EquivalentCMT Health PTE., Ltd.
FDA 510(k) clearance K260855 for Profoject Safety Pen Needles, Substantially Equivalent on 2026-06-10. Applicant: CMT Health PTE., Ltd.. Device class: 2.
Summary
CMT Health's Profoject Safety Pen Needles are filed under FMI, single lumen hypodermic needles. The record gives no gauges or lengths.
Class II, 21 CFR 880.5570. General Hospital is both the classification panel and the review panel. It was a Traditional 510(k).
CMT Health filed from Singapore. Review took 86 calendar days (March 16 to June 10, 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
- K260739 — Profoject Pen Needles (Model A; Model B)
- K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
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.