# K092246: Nipro Needleless Transfer Device, Models: M285503 and M285505

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Nov 12, 2009 after 107 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K811269 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972117: Msi Bottleflow, Transflow, Vialflow, Medical Specialty Innovations, Inc. (Msi) (1997) Summary page 1.

## Indications for use
The NIPRO Needleless Transfer Device is a sterile device for the aseptic transfer of solutions from container to container or reconstituting medications.

Source page: https://510kreport.com/device/K092246
Methodology: https://510kreport.com/methodology