DeviceClearance

Lancing device— 510(k) K262135

Substantially Equivalent

Tianjin Huahong Technology Co., Ltd.

FDA 510(k) clearance K262135 for Lancing device, Substantially Equivalent on 2026-08-18. Applicant: Tianjin Huahong Technology Co., Ltd.. Device class: 2.

Summary

Tianjin Huahong Technology filed a Lancing device under product code QRL, multiple use blood lancets for single patient use only. The device name is generic, and the record lists no model numbers.

Class II, 21 CFR 878.4850. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).

Huahong filed from Tianjin, China. The substantially equivalent decision came 54 calendar days after receipt (June 25 to August 18, 2026).

Clearance details

Applicant
Tianjin Huahong Technology Co., Ltd.
Product code
Product code QRL
Device class
Class 2
Regulation
21 CFR 878.4850
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tianjin, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code QRL

product code QRL
Other
1
Total
1

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.