# K123684: Sol-Care Safety Needle

- Pathway: 510(k) (Traditional)
- Applicant: Sol-Millennium Medical
- Decided: May 8, 2013 after 159 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010188 (2001). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010188: BD Eclipse Hypodermic Needle, Bd Medical Systems (2001) Summary page 1.

## Most influential descendants
- K222271: Verisafe Safety sterile needles (2023), 0 descendants of its own
- K152183: EXELINT SecureTouch Safety Hypodermic Needle (2015), 0 descendants of its own

## Recalls of this device
- Jan 15, 2020 · Class II · Z-1455-2020: Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a need
- Jan 15, 2020 · Class II · Z-1454-2020: Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a need

## Indications for use
The Sol-Care Safety Hypodermic Needle is used in conjunction with a standard syringe. This device is used for aspiration and administration of medication. The Sol-Care Safety Hypodermic Needle safety mechanism covers the needle after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

Source page: https://510kreport.com/device/K123684
Methodology: https://510kreport.com/methodology