# K222681: Altaviz Needle Kit

- Pathway: 510(k) (Traditional)
- Applicant: Altaviz, LLC
- Decided: Dec 5, 2022 after 90 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K771203 (1977). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082820: K-Pack II Needle - 29G Thin Wall, Terumo Europe N.V. (2008) Summary page 4.

## Most influential descendants
- K231261: Altaviz Needle Kit II (2023), 0 descendants of its own

## Recalls of this device
- Aug 22, 2023 · Class II · Z-2653-2023: 19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural variations in this 19-g

## Indications for use
The Altaviz Needle Kit 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 is indicated for intravitreal use.

Source page: https://510kreport.com/device/K222681
Methodology: https://510kreport.com/methodology