# K971593: Silcraft Access 3700 Whirlpool System, Silcraft Model 1800 Lift, Silcraft Disinfectant

- Pathway: 510(k) (Traditional)
- Applicant: The Silcraft Corp.
- Decided: Feb 26, 1998 after 301 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. The FDA summary names its predicate without a number.
- (no number) Grand Traverse Technologies, Inc.’s Freedom Bath: named in the summary without a submission number
- (no number) Dutton-Lainson Company’s Sanitas Whirlpool Bathing System: named in the summary without a submission number
- (no number) Arjo-Century, Inc.’s Whirlpool Bathing System: named in the summary without a submission number
- (no number) Arjo-Century, Inc.’s Height Adjustment Tank with Hygiene Chair: named in the summary without a submission number
- (no number) Setma, Inc.’s Setma VHT Bathing System: named in the summary without a submission number

## Indications for use
Models 2001, 3700B, 3700D, 3600, and 3600XL: Full immersion bathing and hydromassage of the lower extremities of patients in a sitting position. Models 2300 and 3300: Full immersion and hydromassage of patients in a sitting position. Models 4300, 5300, 4400SS, and 5400SS: Full immersion bathing and hydromassage of patients in a reclining position.

Source page: https://510kreport.com/device/K971593
Methodology: https://510kreport.com/methodology