# K211214: Sterile Hypodermic Needles for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Azur Medical Company, Inc.
- Decided: Oct 14, 2021 after 174 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: 7 generations back to K904198 (1990). 32 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180417: Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use, Berpu Medical Technology Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K223334: Sterile Hypodermic Needles for Single Use (2022), 1 descendant of its own
- K252631: Profoject™ Disposable Needle (2025), 0 descendants of its own
- K233037: Sterile Hypodermic Needles for Single Use (2023), 0 descendants of its own
- K231519: Revital Cady (2023), 0 descendants of its own

## Indications for use
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer lock or luer slip syringe and injection devices for general purpose fluid injection/aspiration.

Source page: https://510kreport.com/device/K211214
Methodology: https://510kreport.com/methodology