# K012061: Superior Bath, Model 6300

- Pathway: 510(k) (Traditional)
- Applicant: Penner Manufacturing, Inc.
- Decided: Jul 19, 2001 after 17 days
- Product code: ILJ (Bath, Hydro-Massage)
- Device class: 2
- Regulation: 21 CFR 890.5100
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Superior Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.

Source page: https://510kreport.com/device/K012061
Methodology: https://510kreport.com/methodology