Lancing System, Sterile Lancet for Single Use, Lancing Device
K222472 is the FDA 510(k) clearance record for Lancing System, Sterile Lancet for Single Use, Lancing Device, a class II device, cleared for Shandong Lianfa Medical Plastic Products Co. , Ltd. on under FDA product code QRL (Multiple Use Blood Lancet For Single Patient Use Only). FDA's definition for product code QRL reads: "A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes". FDA records list 2 510(k) clearances for Shandong Lianfa Medical Plastic Products Co. , Ltd., from to . As of , FDA records show one recall naming K222472.
Clearance record
- Decision date
- Received
- (106 days to decision)
- Product code
- QRL Multiple Use Blood Lancet For Single Patient Use Only
- Regulation
- 21 CFR 878.4850
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- Shandong Lianfa Medical Plastic Products Co. , Ltd. # 1 Shuangshan Sanjian Rd., Zhangqiu, Jinan, CN
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code QRL
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 1 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 2 |
| August 2026 | 1 |
| September 2026 | 0 |
| October 2026 | 0 |
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