Class Class II
babyLance Safety Heelstick (BLM, BLN, BLP) (K223900)
Description
babyLance Safety Heelstick (BLM, BLN, BLP) by Clinical Innovations, LLC, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223900
Clearance Date2023-02-24
Clearance TypeTraditional
Product CodeFMK
Regulation Number878.4850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223900
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. babyLance Safety Heelstick (BLM, BLN, BLP) (K223900) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K130132 | BABYLANCE HEEL INCISION DEVICE | Medipurpose Pte. , Ltd. | 2013 |
Trace the full predicate network for K223900
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.