# K251111: Cary

- Pathway: 510(k) (Traditional)
- Applicant: Excitus AS
- Decided: May 7, 2025 after 26 days
- Product code: JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K935218 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120065: Plaxtron Suction Unit, Model 88AA51/88AA61 Series, Plaxtron Industrial (M) Sdn. Bhd. (2012) Summary page 5.

## Indications for use
Cary is indicated for removal of fluids from the upper airway. The device creates a negative pressure (vacuum) that draws fluids through disposable suction tube that is connected to a disposable collection canister. The fluids are captured in the collection canister for proper disposal. Cary is for use only on the order of a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use).

Source page: https://510kreport.com/device/K251111
Methodology: https://510kreport.com/methodology