Panels › General, Plastic Surgery › Product code QRL · Class 2
Multiple Use Blood Lancet For Single Patient Use Only
Regulation 878.4850
4510(k)s in 12 months (27 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in QRL
| Company | 510(k)s | Recalls |
|---|---|---|
| Tianjin Huahong Technology Co., Ltd. | 5 | 0 |
| Facet Technologies, LLC | 3 | 0 |
| Ascensia Diabetes Care U.S., Inc. | 2 | 0 |
| Roche Diabetes Care, Inc. | 2 | 0 |
| SteriLance Medical (Suzhou), Inc. | 2 | 0 |
| Arkray, Inc. | 1 | 0 |
| Asahi Polyslider Co., Ltd. | 1 | 0 |
| Beijing Ruicheng Medical Supplies Co., Ltd. | 1 | 0 |
| Bionime Corporation | 1 | 0 |
| Gostar Co., Ltd. | 1 | 0 |
| 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 | K222472 |
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