# K161255: meso-relle (AAL34, AAL36, AM30G)

- Pathway: 510(k) (Traditional)
- Applicant: Biotekne Srl
- Decided: Jan 19, 2017 after 261 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
Longest line of descent: 2 generations back to K051783 (2005). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110606: MV Intradermic Needles; Magic Needle; Magic Needle, M.V.S.R.L. (2011) Summary page 4.

## Most influential descendants
- K230070: MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® (2023), 0 descendants of its own

## Indications for use
The meso-relle needles are intended to inject fluids intradermally.

Source page: https://510kreport.com/device/K161255
Methodology: https://510kreport.com/methodology