510(k) Report

FDA product code · Neurology

Goniometer With Electrodes

NKIClass II21 CFR 888.1500510(k) exempt1 decision since 20040 recalls

FDA lists NKI 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 2004. No recall names this code.

A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording range of motion, acceleration, or forces exerted by a joint. The class II (special controls) goniometer uses transcutaneous adhesive electrode lead wires and patient cables to transmit and record patient data.

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, neurology panel

Twenty years of NKI 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 · NKI

FDA has decided no NKI device since 2007.

Median 510(k) review, days · NKI

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

Recalls per year · NKI

No recall names NKI since 2007.

Adverse event reports per year · NKI

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

Planning a device in NKI? 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 NKI lately?

  • K033193SonosensFriendly Sensors AG · 2004

The one NKI decision →

Related product codes

Other codes under 21 CFR 888.1500.

KQX Goniometer, Ac-Powered