# K110994: Parker 500

- Pathway: 510(k) (Abbreviated)
- Applicant: Arjohuntleigh, Inc.
- Decided: Jul 6, 2011 after 89 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
Longest line of descent: 2 generations back to K883308 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964926: Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height Hydraulic/Fixed Height Electric Reclining/Height Electric, Joerns Healthcare, Inc. (1997) Summary page 2.
- K930665: Century Bathing System, Arjo-Century, Inc. (1995) Summary page 2.
- K001079: Recumbent Bathing Systems, Rhapsody and Primo, Arjo, Inc. (2000) Summary page 2.
- K930624: Sanitas Whirpool Bathing System, Dutton-Lainson Co. (1994) Summary page 2.

## Indications for use
To relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue

Source page: https://510kreport.com/device/K110994
Methodology: https://510kreport.com/methodology