510(k) Report

510(k) · Cleared

Cleared

Ferno Ille HI-LO JR. Mobile Whirlpool, Model 403

K914125510(k) TraditionalCleared Oct 25, 199142-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

Ferno · ILJ Bath, Hydro-Massage

Cleared on Oct 25, 1991 after a 42-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Oct 25, 1991
Review
42 days
Class
Class II
Product code
ILJ
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1996: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK914125 Ferno Ille HI-LO JR. Mobile Whirlpool, Model 403Ferno · 1991
  2. Descendant · cites it directly · 1 of its ownK964926 Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height…Joerns Healthcare, Inc. · 1997
  3. Descendant · 2 generations on · 0 of its ownK110994 Parker 500Arjohuntleigh, Inc. · 2011
  4. Descendant · cites it directly · 0 of its ownK953796 Banks Hydro-Therapy ChairKeith Products, Inc. · 1996

Most influential descendants

Showing 3 of 3 · See all
  • K964926Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height Hydraulic/Fixed Height…Joerns Healthcare, Inc. · 1997 · cites it directly1descendant
  • K110994Parker 500Arjohuntleigh, Inc. · 2011 · 2 generations on0descendants
  • K953796Banks Hydro-Therapy ChairKeith Products, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914125Ferno Ille HI-LO JR. Mobile Whirlpool, Model 403Ferno1991—
+1K964926Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height Hydraulic/Fixed…Joerns Healthcare, Inc.1997—
+2K110994Parker 500Arjohuntleigh, Inc.2011—
+1K953796Banks Hydro-Therapy ChairKeith Products, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
201110
FIG. 1 — Lineage of K914125, 1991–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K964926Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height Hydraulic/Fixed Height…Joerns Healthcare, Inc.19971
K953796Banks Hydro-Therapy ChairKeith Products, Inc.19960

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?

  • Of its descendants, K964926 (Joerns Healthcare, Inc., 1997) has gone furthest, with 1 descendant 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—

More from Ferno

5 FDA decisions under this applicant name. See the company

  • K932260Ferno-Washington Ambulance Cot, 93ES Squad-MateFerno · 1993
  • K931346Ferno-Washington Incubator Transporter,# 29-ITFerno · 1993
  • K924669Ferno-Washington Basket Stretcher, Model 71-WFerno · 1993
  • K924023Ferno Ille Inferno Moist Heat Therapy UT, 916/917Ferno · 1993

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/K914125 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914125: Ferno Ille HI-LO JR. Mobile Whirlpool, Model 403.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914125

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026