# K223327: Sterile Aesthetic Cannula and Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Kindly Enterprise Development Group Co., Ltd.
- Decided: Feb 16, 2023 after 108 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: 1 generation back to K200017 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200017: Eclipse DermaFlex Cannula, Eclipse Medcorp, LLC (2020) Summary page 4.

## Indications for use
The product is intended to use for injecting fluids intradermally. It is for adult only (greater than 21 years old).

Source page: https://510kreport.com/device/K223327
Methodology: https://510kreport.com/methodology