# K231261: Altaviz Needle Kit II

- Pathway: 510(k) (Traditional)
- Applicant: Altaviz, LLC
- Decided: Jul 27, 2023 after 87 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: 5 generations back to K771203 (1977). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222681: Altaviz Needle Kit, Altaviz, LLC (2022) Summary page 4.
- K970370: TSK Sterijekt Premium Disposable Hypodermic Needle, Tsk Laboratory, Japan (1997) Summary page 4.

## Indications for use
The Altaviz Needle Kit II is a convenience kit that includes: A 29G injection needle that is a sterile medical device for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Either an 18G or a 19G 5 micron filter needle that is a sterile medical device for single use intended to draw up fluids into a syringe. The Altaviz Needle Kit II is indicated for intravitreal use.

Source page: https://510kreport.com/device/K231261
Methodology: https://510kreport.com/methodology