# K043038: Biotop Hooksafe Luer-Lock Safety Syringe, Models 3CC/ML, 5CC/ML and 10CC/ML

- Pathway: 510(k) (Special)
- Applicant: Biotop Technology Co., Ltd.
- Decided: Dec 22, 2004 after 48 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: 5 generations back to K000572 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041970: Biotop Hooksafe Safety Syringe, Models 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML and 10CC/ML, Biotop Technology Co., Ltd. (2004) Summary page 1.

## Indications for use
The BIOTOP HookSafeTM LUER-LOCK Safety Syringe; models 3cc/mL, 5cc/mL, and 10cc/mL serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.

Source page: https://510kreport.com/device/K043038
Methodology: https://510kreport.com/methodology