# K001572: Neolus Needle

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: Aug 14, 2000 after 84 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
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K110850: K-Pack II Needle- 27G & 30G Thin Wall (2011), 5 descendants of its own
- 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 (2019), 2 descendants of its own
- K230951: Terumo Injection Filter Needle (NF-3013RBKE05M) (2023), 1 descendant of its own
- K243581: K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (2025), 0 descendants of its own
- K242073: STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K001572
Methodology: https://510kreport.com/methodology