Promisemed X-Safety Pen Needle— 510(k) K261719
Substantially EquivalentPromisemed Hangzhou Meditech Co., Ltd.
FDA 510(k) clearance K261719 for Promisemed X-Safety Pen Needle, Substantially Equivalent on 2026-08-25. Applicant: Promisemed Hangzhou Meditech Co., Ltd.. Device class: 2.
Summary
Promisemed Hangzhou Meditech filed the Promisemed X-Safety Pen Needle under product code FMI, single lumen hypodermic needles. The record gives no gauges, lengths, or model numbers.
Class II, 21 CFR 880.5570. General Hospital is both the classification panel and the review panel, and it came in as a Special 510(k).
Promisemed filed from Hangzhou, China. The substantially equivalent decision came 91 calendar days after receipt (May 26 to August 25, 2026).
Clearance details
- Applicant
- Promisemed Hangzhou Meditech Co., 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
- Special
- Location
- Hangzhou, CN
Recent devices under product code FMI
view all- K261266 — MOWANA Auto Duo
- 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
- K260739 — Profoject Pen Needles (Model A; Model B)
More clearances from Promisemed Hangzhou Meditech Co., Ltd.
view allAdverse 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.