# K050575: Futumeds NO Patient Contact Safety Lancet with Pals System

- Pathway: 510(k) (Traditional)
- Applicant: Futumeds Sdn Bhd
- Decided: Aug 15, 2005 after 161 days
- Product code: MDM (Instrument, Manual, Surgical, General Use)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The device is intended to pierce the epidermal layer of the human skin for the collection of a small volume of blood sample.

Source page: https://510kreport.com/device/K050575
Methodology: https://510kreport.com/methodology