# K113091: Syringes, With or without Needles

- Pathway: 510(k) (Traditional)
- Applicant: Jiangyin Caina Technology Co., Ltd.
- Decided: Oct 28, 2011 after 9 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K072737: CSCS-001A Calcium Scoring Package, Toshiba America Medical Systems, In.C (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K170218: Vesco Medical NRFit Tip Syringes (2017), 4 descendants of its own
- K171131: MHC Standard and NRFit Tip Syringes (2017), 1 descendant of its own
- K212764: Medwell Technology Ltd Syringes, various sizes (2022), 0 descendants of its own
- K182765: 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe (2019), 0 descendants of its own
- K181374: NRFit Syringe (2018), 0 descendants of its own

## Indications for use
Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body. Needles are intended to be used with a legally marketed syringe intend to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K113091
Methodology: https://510kreport.com/methodology