# K214004: CCBIO ASCPO Needle

- Pathway: 510(k) (Traditional)
- Applicant: Cc Biotechnology Corporation
- Decided: Dec 13, 2022 after 357 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: 3 generations back to K010188 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100209: BD Eclipse Needle with Smartslip Technology, Becton, Dickinson & CO (2010) Summary page 4.

## Indications for use
The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.

Source page: https://510kreport.com/device/K214004
Methodology: https://510kreport.com/methodology