# K972867: Craft Duo-Vac Suction Unit, Craft Suction Unit

- Pathway: 510(k) (Traditional)
- Applicant: Rocket Medical Plc
- Decided: Oct 24, 1997 after 81 days
- Product code: ICX (Aniline)
- Device class: 1
- Regulation: 21 CFR 864.1850
- 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 K914220 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914220: Pioneer Pro-Pump, Pioneer Medical, Inc. (1992) Summary page 1.
- K914241: Pioneer Pro-Pump Dual Control, Pioneer Medical, Inc. (1992) Summary page 1.

## Indications for use
A vacuum powered body fluid suction apparatus could be used in a variety of clinical conditions, however, these particular units have been developed to: Provide Low flow regulated negative pressure for general suction and aspiration.

Source page: https://510kreport.com/device/K972867
Methodology: https://510kreport.com/methodology