# K130097: Medmate Transfer Adapter AM5500 & AM5500-NS

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Manufacturing, Inc./ Advanced Med
- Decided: Jul 22, 2014 after 553 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 K010188 (2001). 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)
- K010188: BD Eclipse Hypodermic Needle, Bd Medical Systems (2001) Summary page 1.

## Indications for use
The MedMate Guarded (18g) Needle is used for general purpose injection and aspiration of fluid from vials and ampoules. The MedMate Guarded Needle is compatible for use with standard luer-slip and luer-lock syringes.

Source page: https://510kreport.com/device/K130097
Methodology: https://510kreport.com/methodology