# K153537: Sol-M  Insulin Syringe, Sol-M TB Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Sol-Millennium Medical, Inc.
- Decided: Jun 17, 2016 after 190 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931367 (1993). 22 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112057: KDL Syringes and Needle, Shanghai Kindly Enterprise Dev. Group Co., (2011) Summary page 5.

## Most influential descendants
- K211242: Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes (2021), 3 descendants of its own
- K213560: Verifine Safety Syringe with Fixed Needle (2022), 2 descendants of its own
- K231792: VeriSafe Safety sterile syringes (2023), 1 descendant of its own
- K250192: Verisafe Safety Retractable Insulin Syringes (2025), 0 descendants of its own
- K220713: Sol-Guard Auto-disable Syringe (2023), 0 descendants of its own

## Indications for use
The Sol-M TB Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body. The Sol-M Insulin Syringe with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

Source page: https://510kreport.com/device/K153537
Methodology: https://510kreport.com/methodology