510(k) Report

FDA product code · Orthopedic

Isometer

LZEClass I21 CFR 888.1520510(k) exempt1 decision since 19950 recalls

FDA lists LZE as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 888.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1995. 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, orthopedic panel

Twenty years of LZE 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 · LZE

FDA has decided no LZE device since 2007.

Median 510(k) review, days · LZE

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

Recalls per year · LZE

No recall names LZE since 2007.

Adverse event reports per year · LZE

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

Planning a device in LZE? 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

What has FDA decided in LZE lately?

  • K950178Pharma-Plast Pureline (TM) Comfort (TM) & Clini Sofs Plus Subcutaneous Infusion SetPharma-Plast Intl. A/S · 1995

The one LZE decision →

Related product codes

Other codes under 21 CFR 888.1520.

KQW Goniometer, Nonpowered