510(k) Report

FDA product code · Neurology

Discriminator, Two-Point

GWIClass I21 CFR 882.1200510(k) exempt2 decisions since 19870 recalls

FDA lists GWI as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 882.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 1987. 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, neurology panel

Twenty years of GWI 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 · GWI

FDA has decided no GWI device since 2007.

Median 510(k) review, days · GWI

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

Recalls per year · GWI

No recall names GWI since 2007.

Adverse event reports per year · GWI

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

Planning a device in GWI? 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 GWI lately?

  • K944234TCD or TCD Neuropathy StarJcm Management & Planning Co. · 1995
  • K874300AesthesiometerOrthopedic Systems, Inc. · 1987

All 2 GWI decisions →

Related product codes

Other codes under 21 CFR 882.1200.

LLN Device, Vibration Threshold MeasurementLQW Test, Temperature Discrimination