# K230951: Terumo Injection Filter Needle (NF-3013RBKE05M)

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: Oct 18, 2023 after 197 days
- Product code: QYM (Ophthalmic Needle)
- 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: 6 generations back to K771203 (1977). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192057: K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall, Terumo Europe N.V. (2019) Summary page 6.

## Most influential descendants
- K242073: STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (2024), 0 descendants of its own

## Indications for use
The Terumo Injection Filter Needle is intended to inject fluids. The Terumo Injection Filter Needle is indicated for general application - for treatment - injection of fluids into parts of the body below the surface of the skin and into the vitreous.

Source page: https://510kreport.com/device/K230951
Methodology: https://510kreport.com/methodology