# K200017: Eclipse DermaFlex Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Eclipse Medcorp, LLC
- Decided: Nov 5, 2020 after 307 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K090317: Babi*Plus Bubble Pap Valve, A Plus Medical (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K242741: ACE Cannula (2025), 0 descendants of its own
- K223327: Sterile Aesthetic Cannula and Hypodermic Needle (2023), 0 descendants of its own

## Indications for use
The Eclipse DermaFlex Cannula is intended to inject fluids intradermally.

Source page: https://510kreport.com/device/K200017
Methodology: https://510kreport.com/methodology