510(k) Report

510(k) · Cleared

Cleared

Thermotron 918

K860082510(k) TraditionalCleared Mar 27, 198678-day reviewClass II21 CFR 890.5275

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

Medical Microwave Research Corp. · IOA Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat

Cleared on Mar 27, 1986 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 27, 1986
Review
78 days
Class
Class II
Product code
IOA
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K860082Source: 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.

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What was it cleared against?

FDA has not posted a summary or statement for it, 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 IOA devices

IOA Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IOA

FDA has decided no IOA device since 2007.

Median 510(k) review, days · IOA

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

Recalls per year · IOA

No recall names IOA since 2007.

Adverse event reports per year · IOA

No MAUDE report names IOA since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in IOA

The IOA category page

  • K941567Diathermy Device-MicrofocusCheung Laboratories, Inc. · 1996
  • K895000Nemectron MicrowaveNemectron Medical, Inc. · 1990
  • K862029Siemens Radiotherm 706, Microwave Therapy UnitElmed, Inc. · 1986

https://510kreport.com/device/K860082 · printed Nov 4, 2026

Cite this page

510(k) Report. “K860082: Thermotron 918.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K860082

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