510(k) Report

FDA product code · Physical medicine

Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat

LXFClass III21 CFR 890.5300PMA required0 decisions0 recalls

0 FDA decisions. 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 LXF 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 · LXF

FDA has decided no LXF device since 2007.

Median 510(k) review, days · LXF

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

Recalls per year · LXF

No recall names LXF since 2007.

Adverse event reports per year · LXF

No MAUDE report names LXF 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 — LXF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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

See the 510(k) Report

Related product codes

Other codes under 21 CFR 890.5300.

IMI Ultrasonic Diathermy For Use In Applying…PFW Stationary Ultrasonic Diathermy Device For Use…