510(k) · Cleared

Cleared

Silcraft Access 3700 Whirlpool System, Silcraft Model 1800 Lift, Silcraft Disinfectant

K971593510(k) TraditionalCleared Feb 26, 1998301-day reviewClass II21 CFR 890.5100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

The Silcraft Corp. · ILJ Bath, Hydro-Massage

Cleared on Feb 26, 1998 after a 301-day review. The FDA summary names its predicate without a number.

Decided: Feb 26, 1998
Review: 301 days
Class: Class II
Product code: ILJ
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K971593Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ILJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Recalls
*	—	Grand Traverse Technologies, Inc.’s Freedom Bath Named without a submission number	—
*	—	Dutton-Lainson Company’s Sanitas Whirlpool Bathing System Named without a submission number	—
*	—	Arjo-Century, Inc.’s Whirlpool Bathing System Named without a submission number	—
*	—	Arjo-Century, Inc.’s Height Adjustment Tank with Hygiene Chair Named without a submission number	—
*	—	Setma, Inc.’s Setma VHT Bathing System Named without a submission number	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All ILJ devices

ILJ Bath, Hydro-Massage: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ILJ

1in 2011

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILJ

Too few ILJ 510(k)s in any year since 2007 to give a median.

Recalls per year · ILJ

No recall names ILJ since 2007.

Adverse event reports per year · ILJ

11in 2025

2007high 210 (2013) · low 6 (2021)2025

MAUDE reports naming product code ILJ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	14
2008	0	—	7
2009	1	—	22
2010	0	—	10
2011	1	—	12
2012	0	—	85
2013	0	—	210
2014	0	—	188
2015	0	—	72
2016	0	—	57
2017	0	—	26
2018	0	—	21
2019	0	—	22
2020	0	—	14
2021	0	—	6
2022	0	—	12
2023	0	—	13
2024	0	—	11
2025	0	—	11
2026	0	—	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971593 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971593: Silcraft Access 3700 Whirlpool System, Silcraft Model 1800 Lift, Silcraft Disinfectant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971593

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026