# K944941: Piston Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Martell Medical Products, Inc.
- Decided: Dec 5, 1994 after 59 days
- Product code: CBT (Arterial Blood Sampling Kit)
- Device class: 1
- Regulation: 21 CFR 868.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Sep 8, 2022 · Class II · Z-1779-2022: The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unu

Source page: https://510kreport.com/device/K944941
Methodology: https://510kreport.com/methodology