# K220184: Pump Alignment Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Caina Medical Co.,Ltd
- Decided: Jul 21, 2022 after 178 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
Longest line of descent: 1 generation back to K980987 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980987: Becton Dickinson Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 5.

## Indications for use
The Pump Alignment Syringe is intended for use by healthcare professionals for injection of fluids for medical purposes into patients of all ages, including neonates in a controlled manner with compatible infusion pumps. The Pump Alignment Syringe can also be used for manual injection of fluids for medical purposes.

Source page: https://510kreport.com/device/K220184
Methodology: https://510kreport.com/methodology