Class Class II
Disposable Safety Lancets (K223313)
Description
Disposable Safety Lancets by Huaian Hening Medical Instruments Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223313
Clearance Date2023-01-23
Clearance TypeTraditional
Product CodeFMK
Regulation Number878.4850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223313
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Disposable Safety Lancets (K223313) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K101145 | SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, S... | Medipurpose Pte. , Ltd. | 2010 |
Trace the full predicate network for K223313
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.