510(k) K222472 ยท QRL Multiple Use Blood Lancet For Single Patient Use Only
Lancing System, Sterile Lancet for Single Use, Lancing Device
| Applicant | Shandong Lianfa Medical Plastic Products Co. , Ltd., Jinan, CN |
| Decision | Substantially Equivalent, Nov 30, 2022 |
| Received | Aug 16, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222472
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2025 | Home Health US, Incorporated One Step Sterile Lancet for Single Use (3 sizes):
06949517008861 30g
06949517008854 28g
06949517008847 23g
The Lancing System is intended for the hygienic collection of capillary blood for test Open, Classified |
QRL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.