510(k) Report

FDA product code · Radiology

Device, Beam Limiting, Teletherapy, Radionuclide

IWDClass II21 CFR 892.5750510(k) required1 decision since 19970 recalls

1 FDA decision since 1997. No recall names this code. The most-cited predicate is K964607, named by 1 later device.

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, radiology panel

Twenty years of IWD 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 · IWD

FDA has decided no IWD device since 2007.

Median 510(k) review, days · IWD

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

Recalls per year · IWD

No recall names IWD since 2007.

Adverse event reports per year · IWD

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code IWD, 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
20070—00
20080—00
20090—01
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 — IWD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IWD? 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

Which predicates do IWD devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K964607Theraton 1000ETheratronics, Inc. · 19971cites it

Which IWD devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K964607Theraton 1000ETheratronics, Inc. · 19971generation

What has FDA decided in IWD lately?

  • K964607Theraton 1000ETheratronics, Inc. · 19971 recall

The one IWD decision →

Related product codes

Other codes under 21 CFR 892.5750.

IWB System, Radiation Therapy, Radionuclide