510(k) Report

510(k) · Cleared

Cleared

Chattanooga Dry Heat Whirlpool, Model 2000

K011243510(k) TraditionalCleared Jul 6, 200174-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

Chattanooga Group, Inc. · LSB Unit, Fluidotherapy

Cleared on Jul 6, 2001 after a 74-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jul 6, 2001
Review
74 days
Class
Class II
Product code
LSB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K011243Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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

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  • 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?

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 LSB devices

LSB Unit, Fluidotherapy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LSB

FDA has decided no LSB device since 2007.

Median 510(k) review, days · LSB

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

Recalls per year · LSB

No recall names LSB since 2007.

Adverse event reports per year · LSB

2in 2025

2010: 12011: 12015: 32018: 12019: 22021: 12025: 2
2007high 3 (2015) · low 0 (2007)2025

MAUDE reports naming product code LSB, 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—00
20080—00
20090—00
20100—01
20110—01
20120—00
20130—00
20140—00
20150—03
20160—00
20170—00
20180—01
20190—02
20200—00
20210—01
20220—00
20230—00
20240—00
20250—02
20260—0—

More from Chattanooga Group, Inc.

70 FDA decisions under this applicant name. See the company

  • K982317Vectra ComboChattanooga Group, Inc. · 1999
  • K982324Vectra Pro Models 2 and 4Chattanooga Group, Inc. · 1999
  • K982321Vectra Stim Models 200 and 400Chattanooga Group, Inc. · 1999
  • K982829Forte, Model CPS UltrasoundChattanooga Group, Inc. · 1998
  • K982830Forte, Models CPS 400 Combo, CPS 200 ComboChattanooga Group, Inc. · 1998

Recent decisions in LSB

The LSB category page

  • K011768Thermo-Therapy, Models TT-101, TT-201, and TT-202Thermo-Electric Co. · 2001
  • K896817Model T11 Fluidotherapy UnitHenley Intl. · 1991
  • K871802Model K210 and K211 Fluidotherapy UnitsHenley Intl. · 1987

https://510kreport.com/device/K011243 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011243: Chattanooga Dry Heat Whirlpool, Model 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011243

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