# K101214: Guardian Connection

- Pathway: 510(k) (Traditional)
- Applicant: Maulin Medical, LLC
- Decided: Jul 23, 2010 after 84 days
- Product code: FPD (Tube, Feeding)
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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 K072652 (2008). 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)
- K072652: Enteral Feeding Spike Adapter, Cedic S.R.L. (2008) Summary page 1.

## Indications for use
The GUARDIAN CONNECTIONTM is designed to be used with standard adult tapered feeding tube connectors to secure the connection.

Source page: https://510kreport.com/device/K101214
Methodology: https://510kreport.com/methodology