510(k) Report

510(k) · Cleared

Cleared

Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height Hydraulic/Fixed Height Electric Reclining/Height Electric

K964926510(k) TraditionalCleared Nov 3, 1997329-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

Joerns Healthcare, Inc. · ILJ Bath, Hydro-Massage

Cleared on Nov 3, 1997 as substantially equivalent to K923637 (Arjo-Century, Inc., 1993) and 3 other predicates after a 329-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.

Decided
Nov 3, 1997
Review
329 days
Class
Class II
Product code
ILJ
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K883308 (1988). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor2011: 1 descendant clearedK883308 · Parker Bathing System · Mid-Canada Medical · 19881990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant K883308 · Parker Bathing System · Mid-Canada Medical · 19880
  1. Root · 1 generation backK883308 Parker Bathing SystemMid-Canada Medical · 1988
  2. This deviceK964926 Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height…Joerns Healthcare, Inc. · 1997
  3. Descendant · cites it directly · 0 of its ownK110994 Parker 500Arjohuntleigh, Inc. · 2011

Most influential descendants

Showing 1 of 1 · See all
  • K110994Parker 500Arjohuntleigh, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K883308Parker Bathing SystemMid-Canada Medical1988—
0 (this device)K964926Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height Hydraulic/Fixed…Joerns Healthcare, Inc.1997—
+1K110994Parker 500Arjohuntleigh, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199110
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K964926, 1988–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

TypeNumberDeviceApplicantDecidedRecalls
*K923637Arjo-Century Arm and Leg Tank System
Summary page 1
…athing Systems Classification Name: Bath, hydro-massage (89ILJ) Class Il per 21 C.F.R. § 890.5100 (immersion hydrobath) Predicate Devices: Arjo-Century Arm and Leg Tank K923637 Ferno llle Hi-Lo Jr. Mobile Whirlpool K914125 Arjo-Century Spa Shell K904106 Parker Bath System K883308 Description: The Parker…
Arjo-Century, Inc.1993—
*K914125Ferno Ille HI-LO JR. Mobile Whirlpool, Model 403
Summary page 1
…o-massage (89ILJ) Class Il per 21 C.F.R. § 890.5100 (immersion hydrobath) Predicate Devices: Arjo-Century Arm and Leg Tank K923637 Ferno llle Hi-Lo Jr. Mobile Whirlpool K914125 Arjo-Century Spa Shell K904106 Parker Bath System K883308 Description: The Parker Bath System consists of a fiberglass base uni…
Ferno1991—
*K904106Spa Shell
Summary page 1
…21 C.F.R. § 890.5100 (immersion hydrobath) Predicate Devices: Arjo-Century Arm and Leg Tank K923637 Ferno llle Hi-Lo Jr. Mobile Whirlpool K914125 Arjo-Century Spa Shell K904106 Parker Bath System K883308 Description: The Parker Bath System consists of a fiberglass base unit and a movable fiberglass tub…
Century Manufacturing Co.1990—
*K883308Parker Bathing System
Summary page 1
…sion hydrobath) Predicate Devices: Arjo-Century Arm and Leg Tank K923637 Ferno llle Hi-Lo Jr. Mobile Whirlpool K914125 Arjo-Century Spa Shell K904106 Parker Bath System K883308 Description: The Parker Bath System consists of a fiberglass base unit and a movable fiberglass tub unit. The base unit contain…
Mid-Canada Medical1988—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110994Parker 500Arjohuntleigh, Inc.20110

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K110994 (Arjohuntleigh, Inc., 2011) has gone furthest, with 0 descendants of its own.

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

2009: 12011: 1
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

2007: 142008: 72009: 222010: 102011: 122012: 852013: 2102014: 1882015: 722016: 572017: 262018: 212019: 222020: 142021: 62022: 122023: 132024: 112025: 11
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—014
20080—07
20091—022
20100—010
20111—012
20120—085
20130—0210
20140—0188
20150—072
20160—057
20170—026
20180—021
20190—022
20200—014
20210—06
20220—012
20230—013
20240—011
20250—011
20260—0—

What is it indicated for?

To relieve pain and itching and as an aid in the healing of inflamed and traumatized tissue and as a setting for removal of contaminated tissue.

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

More from Joerns Healthcare, Inc.

2 FDA decisions under this applicant name. See the company

  • K951735Joerns Healthcare, Inc. Full Length Telescoping RailJoerns Healthcare, Inc. · 19951 recall

Recent decisions in ILJ

The ILJ category page

  • K110994Parker 500Arjohuntleigh, Inc. · 2011
  • K082951Immersion HydrobathArjo Hospital Equipment AB · 2009
  • K052479MBATH 1000 (60)Enneking Medical, Inc. · 2006
  • K040772Pacific Recumbent Height-Adjustable Bath SystemPenner Manufacturing, Inc. · 200410 recalls
  • K012057Cascade Bath, Model 6900Penner Manufacturing, Inc. · 2001

https://510kreport.com/device/K964926 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964926: Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height Hydraulic/Fixed Height Electric Reclining/Height Electric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964926

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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