# K132681: Sol-Guard Insulin and Tuberculin Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Sol-Millennium Medical, Inc.
- Decided: May 22, 2014 after 267 days
- Product code: MEG (Syringe, Antistick)
- 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: 2 generations back to K922522 (1992). 2 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061492: Monoject Magellan Insulin and Tuberculin Safety Syringe, Tyco Healthcare (2006) Summary page 1.

## Most influential descendants
- K192551: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle (2020), 14 descendants of its own
- K210443: PLPT LDV (Low Dead Volume) Sterile Syringe (2021), 6 descendants of its own
- K213010: FEELject LDV (Low dead volume) syringe (2023), 2 descendants of its own
- K231856: TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) (2024), 1 descendant of its own
- K221860: PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile Syringe (2023), 1 descendant of its own

## Indications for use
The Sol-Guard Tuberculin (TB) Safety Syringe is intended for the delivery of Tuberculin. The Sol-Guard TB Safety Syringe Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield guards against accidental needle stick. The Sol-Guard Insulin Safety Syringe is intended for the delivery of U-100 insulin. The Sol-Guard Insulin Safety Syringe Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield guards against accidental needle stick.

Source page: https://510kreport.com/device/K132681
Methodology: https://510kreport.com/methodology