510(k) Report

510(k) · Cleared

Recalled · Class III · 2025

Pacific Recumbent Height-Adjustable Bath System

K040772510(k) TraditionalCleared Apr 5, 200410-day reviewClass II21 CFR 890.5100Recalls 10

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

Penner Manufacturing, Inc. · ILJ Bath, Hydro-Massage

Cleared on Apr 5, 2004 after a 10-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 10 times.

Decided
Apr 5, 2004
Review
10 days
Class
Class II
Product code
ILJ
Recalls
10
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K040772Source: FDA 510(k) database · 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 13, 2025Class IIIZ-1505-2026Error in labelingThe device does not bear a unique device identifier.
Aug 13, 2025Class IIIZ-1503-2026Error in labelingThe device does not bear a unique device identifier.
Aug 13, 2025Class IIIZ-1504-2026Error in labelingThe device does not bear a unique device identifier.
Aug 13, 2025Class IIIZ-1507-2026Error in labelingThe device does not bear a unique device identifier.
Aug 13, 2025Class IIIZ-1501-2026Error in labelingThe device does not bear a unique device identifier.
Aug 13, 2025Class IIIZ-1502-2026Error in labelingThe device does not bear a unique device identifier.
Aug 13, 2025Class IIIZ-1508-2026Error in labelingThe device does not bear a unique device identifier.
Aug 13, 2025Class IIIZ-1499-2026Error in labelingThe device does not bear a unique device identifier.
Aug 13, 2025Class IIIZ-1500-2026Error in labelingThe device does not bear a unique device identifier.
Aug 13, 2025Class IIIZ-1506-2026Error in labelingThe device does not bear a unique device identifier.

The 5 latest of 10 recalls; the web page lists all.

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

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?

The Pacific Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only. The Pacific Bath will not be marketed for therapeutic or other medical uses.

Indications for use as stated in the FDA 510(k) statement.

More from Penner Manufacturing, Inc.

3 FDA decisions under this applicant name. See the company

  • K012061Superior Bath, Model 6300Penner Manufacturing, Inc. · 2001
  • K012057Cascade Bath, Model 6900Penner Manufacturing, Inc. · 2001

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
  • K012061Superior Bath, Model 6300Penner Manufacturing, Inc. · 2001
  • K012057Cascade Bath, Model 6900Penner Manufacturing, Inc. · 2001

https://510kreport.com/device/K040772 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040772: Pacific Recumbent Height-Adjustable Bath System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040772

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