Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)— 510(k) K240806

Substantially Equivalent

Tianjin Huahong Technology Co., Ltd.

FDA 510(k) clearance K240806 for Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.), Substantially Equivalent on 2024-05-21. Applicant: Tianjin Huahong Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Tianjin Huahong Technology Co., Ltd.
Product code: Code FMK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2024-03-25
Decision date: 2024-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMK

K262526 — Safety lancet (XL)2026-09-13
K261045 — Verifine Safety Lancets2026-05-01
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

More clearances from Tianjin Huahong Technology Co., Ltd.

K262135 — Lancing device2026-08-18
K260845 — Huahong Sharps Container (HHR-I, HHR-II)2026-08-05
K262211 — Lancet2026-07-22
K253706 — Lancing device (HH-XV-T)2025-12-09
K251694 — safety lancet2025-06-26

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.