510(k) Report

FDA product code · Physical medicine

Manipulator, Plunger-Like Joint

LXMClass U510(k) required32 decisions since 19880 recalls

32 FDA decisions since 1988. 510(k) reviews decided 2021–2025 took a median of 56 days (half between 56 and 56). No recall names this code. The most-cited predicate is K003185, named by 5 later devices.

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 LXM 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 · LXM

1in 2024

2007: 12008: 22012: 12014: 12016: 12018: 12019: 12024: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXM

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

Recalls per year · LXM

No recall names LXM since 2007.

Adverse event reports per year · LXM

1in 2020

2009: 12016: 32018: 12020: 1
2007high 3 (2016) · low 0 (2007)2025

MAUDE reports naming product code LXM, 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
20071—00
20082—00
20090—01
20100—00
20110—00
20121—00
20130—00
20141—00
20150—00
20161—03
20170—00
20181—01
20191—00
20200—01
20210—00
20220—00
20230—00
20241—00
20250—00
20260—0—
FIG. 1 — LXM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LXM? 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