510(k) Report

FDA product code · Physical medicine

Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat

IOAClass II21 CFR 890.5275510(k) required4 decisions since 19860 recalls

4 FDA decisions since 1986. No recall names this code.

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

FIG. A — Illustration, physical medicine panel

Twenty years of IOA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — IOA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IOA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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Related product codes

Other codes under 21 CFR 890.5275.