# K190962: Bella-mu

- Pathway: 510(k) (Traditional)
- Applicant: U-Needle B.V.
- Decided: Feb 3, 2020 after 297 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Bella-mu is indicated for intradermal injections of FDA approved drugs for patients 18 years of age and older. The Bella-mu is to be inserted in the dermis of the suprascapular, deltoid, waist, or thigh regions.

Source page: https://510kreport.com/device/K190962
Methodology: https://510kreport.com/methodology