510(k) · Cleared

Cleared

Parker 500

K110994510(k) AbbreviatedCleared Jul 6, 201189-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

Arjohuntleigh, Inc. · ILJ Bath, Hydro-Massage

Cleared on Jul 6, 2011 as substantially equivalent to K964926 (Joerns Healthcare, Inc., 1997) and 3 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1988.

Decided: Jul 6, 2011
Review: 89 days
Class: Class II
Product code: ILJ
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K883308 (1988). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK883308 Parker Bathing SystemMid-Canada Medical · 1988
1 generation backK964926 Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height…Joerns Healthcare, Inc. · 1997
This deviceK110994 Parker 500Arjohuntleigh, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K883308	Parker Bathing System	Mid-Canada Medical	1988	—
−1	K964926	Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height Hydraulic/Fixed…	Joerns Healthcare, Inc.	1997	—
0 (this device)	K110994	Parker 500	Arjohuntleigh, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1991	1	0
1993	1	0
1994	1	0
1995	1	0
2000	1	0

FIG. 1 — Lineage of K110994, 1988–2011Source: FDA 510(k) summaries, read by 510(k) Report · 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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K964926	Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height Hydraulic/Fixed Height… Summary page 2 …Parker 500 is substantially equivalent to the following predicate devices: * Parker 420 (the manufacturers predecessor device cleared under K964926). a Century / Saflift (Adjo-Century Inc, cleared under K930665) *Rhapsody (Arjo Inc, cleared under K001079)…	Joerns Healthcare, Inc.	1997	—
*	K930665	Century Bathing System Summary page 2 …devices: * Parker 420 (the manufacturers predecessor device cleared under K964926). a Century / Saflift (Adjo-Century Inc, cleared under K930665) Rhapsody (Arjo Inc, cleared under K001079) Whirlpool bathing system (DUTTON-LAINSON CO), cleared under…	Arjo-Century, Inc.	1995	—
*	K001079	Recumbent Bathing Systems, Rhapsody and Primo Summary page 2 …ecessor device cleared under K964926). a Century / Saflift (Adjo-Century Inc, cleared under K930665) Rhapsody (Arjo Inc, cleared under K001079) Whirlpool bathing system (DUTTON-LAINSON CO), cleared under K(930624) 1.5 Description of the Device…	Arjo, Inc.	2000	—
*	K930624	Sanitas Whirpool Bathing System Summary page 2 …Inc, cleared under K930665) Rhapsody (Arjo Inc, cleared under K001079) Whirlpool bathing system (DUTTON-LAINSON CO), cleared under K(930624) 1.5 Description of the Device The bathing system consists of a tub composed of fiberglass, which is covered b…	Dutton-Lainson Co.	1994	—

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.

What does this lineage say?

The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
None of the 8 ancestors has a 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. 2011, this device’s year, is highlighted.

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?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110994 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110994: Parker 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110994

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Record history

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