Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)
by Tianjin Huahong Technology Co., Ltd.
510(k) K243306
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK243306 | Date15 Nov 2024 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- QRL
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4850
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Multiple Use Blood Lancet for Single Patient Use Only, designed for capillary blood sampling. It includes both disposable lancets and reusable lancing devices, which pierce the skin to obtain small blood samples for diagnostic testing. The lancets vary in blade length and depth settings to accommodate different patient needs, ensuring precise and controlled blood collection. The lancing devices are paired with these lancets to facilitate the procedure safely and efficiently.
The lancets and lancing devices are intended for single-patient use only, adhering to infection control protocols. They are supplied sterile and packaged individually for clinical settings, including hospitals, laboratories, and home healthcare environments. The devices are classified as Class II under regulatory frameworks and comply with FDA 510(k) clearance and MDR (Medical Device Regulation) requirements. Each model (e.g., HH-X-T, HH-XV-T) is uniquely identified for traceability and proper usage.
Other devices from Tianjin Huahong Technology Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
Are the lancets and lancing devices reusable, or are they meant for single-use only?
The lancets and lancing devices are designed for single-patient use only, even though the lancing devices themselves are reusable. The lancets are disposable and intended to be discarded after one use to ensure infection control and safety. This aligns with the device’s classification as a *Multiple Use Blood Lancet for Single Patient Use Only* and adheres to strict clinical protocols.
How do I know which lancet or lancing device model is right for my patient’s needs?
The lancets and lancing devices come in multiple models (e.g., HH-X-T, HH-XV-T) with varying blade lengths and depth settings to accommodate different patient needs, such as skin thickness or sensitivity. The manufacturer provides specific guidance for each model, and the unique identification codes (e.g., HH-X-T) ensure proper selection for precise and controlled blood collection. Always refer to the packaging or manufacturer instructions for compatibility.
Are the lancets and lancing devices sterile when they arrive, and how should they be stored?
Yes, the lancets and lancing devices are supplied sterile and packaged individually for clinical use. To maintain sterility, store them in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s storage instructions on the packaging to prevent contamination or degradation before use.
What regulatory pathways have these devices undergone, and how does that affect their use?
The devices have undergone FDA 510(k) clearance and comply with the EU Medical Device Regulation (MDR). They are classified as Class II devices, meaning they meet stringent safety and performance requirements. While these clearances confirm regulatory compliance, they do not dictate clinical indications—only that the devices meet established standards for capillary blood sampling when used as intended (single-patient use). Always follow local healthcare guidelines for proper use.