# K040545: Otter Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Otter (China) Technology Co., Ltd.
- Decided: Apr 22, 2004 after 51 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Duopro Safety Syringe: named in the summary without a submission number
- (no number) SecureGard Retractable Safety Syringe: named in the summary without a submission number
- (no number) SEZ Safety Syringe: named in the summary without a submission number
- (no number) Nipro hypodermic needle: named in the summary without a submission number

## Most influential descendants
- K142435: 3S Safety Syringe with/without Needle (2015), 2 descendants of its own
- K152606: Jeesung Safety Syringe and Single Use Needles (2016), 1 descendant of its own
- K212518: Jeesung Safety Syringe and Single Use Needles (2022), 0 descendants of its own
- K050116: Uniqsafe Rotatable, Retractable Safety Syringes (2005), 0 descendants of its own

## Indications for use
The Otter Safety Syringe is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Source page: https://510kreport.com/device/K040545
Methodology: https://510kreport.com/methodology