# K182146: Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Sol-Millennium Medical, Inc.
- Decided: Dec 3, 2018 after 117 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 K972404 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172763: Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder, Zhejiang Kindly Medical Devices Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K201009: CHIRAVAC Blood Collection Needles (2021), 0 descendants of its own

## Indications for use
The Sol-M Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood. The Sol-Care Safety Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Sol-Care Safety Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Sol-M Blood Collecting Set is intended to be used with vacuum blood collection tube for the collection of venous blood.

Source page: https://510kreport.com/device/K182146
Methodology: https://510kreport.com/methodology