# K050131: Insosafe Bak'snap Retractable Insulin Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: M.K. Meditech Co., Ltd.
- Decided: Apr 5, 2005 after 74 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: 4 generations back to K000572 (2000). 12 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031594: Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray, M.K. Meditech Co., Ltd. (2003) Summary page 1.
- K040036: Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905, Inviro Medical (2004) Summary page 1.
- K992734: Becton Dickinson Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1999) Summary page 1.

## Most influential descendants
- K152808: U&U Insulin Syringe with/without Safety Retractable Device (2016), 5 descendants of its own
- K202570: Insulin Syringe, Insulin Syringe with Safety Retractable (2021), 2 descendants of its own
- K220061: Safety Insulin Syringes (2022), 1 descendant of its own
- K230061: Insulin Syringe (2023), 0 descendants of its own
- K191639: TK Insulin Syringe with/without Saftey Retractable Device (2020), 0 descendants of its own

## Indications for use
The InsoSAFE Bak'SNAP Retractable Insulin Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe intended for subcutaneous injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Source page: https://510kreport.com/device/K050131
Methodology: https://510kreport.com/methodology