# K241646: Ortiv (Ortiv-BL, Ortiv-WH)

- Pathway: 510(k) (Traditional)
- Applicant: Mvitro Co., Ltd.
- Decided: Nov 1, 2024 after 147 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981746 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172818: LMT-3000, Lameditech Co., Ltd. (2018) Summary page 5.

## Indications for use
The ORTIV is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples in both institutional and at-home settings.

Source page: https://510kreport.com/device/K241646
Methodology: https://510kreport.com/methodology