Verifine Safety Lancets— 510(k) K261045

Name: FDA 510(k) clearance K261045
Creator: U.S. Food and Drug Administration
Published: 2026-05-01

Substantially Equivalent

Promisemed Hangzhou Meditech Co., Ltd.

FDA 510(k) clearance K261045 for Verifine Safety Lancets, Substantially Equivalent on 2026-05-01. Applicant: Promisemed Hangzhou Meditech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Promisemed Hangzhou Meditech Co., Ltd.
Product code: Code FMK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2026-03-31
Decision date: 2026-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Hangzhou City, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMK

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K262526 — Safety lancet (XL)2026-09-13
K260191 — Safety lancet (XXXVII)2026-03-31
K253605 — Safety Heel Lancet2026-02-20
K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)2026-02-12
K251694 — safety lancet2025-06-26

More clearances from Promisemed Hangzhou Meditech Co., Ltd.

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K261719 — Promisemed X-Safety Pen Needle2026-08-25
K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12
K254273 — Verisafe Safety Sterile Needles (SSN)2026-04-16
K250192 — Verisafe Safety Retractable Insulin Syringes2025-12-10
K250961 — Blood collection tube holders2025-06-04

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.