510(k) Report

FDA product code · Physical medicine

Head Halter, Traction

IRSClass I21 CFR 890.5925510(k) exempt1 decision since 19770 recalls

FDA lists IRS as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 890.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1977. 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, physical medicine panel

Twenty years of IRS 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 · IRS

FDA has decided no IRS device since 2007.

Median 510(k) review, days · IRS

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

Recalls per year · IRS

No recall names IRS since 2007.

Adverse event reports per year · IRS

1in 2020

2010: 12012: 22019: 12020: 1
2007high 2 (2012) · low 0 (2007)2025

MAUDE reports naming product code IRS, 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—00
20100—01
20110—00
20120—02
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — IRS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IRS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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What has FDA decided in IRS lately?

  • K770724Traction Devices, Intermittent, TXChattanooga Pharmacal Co. · 1977

The one IRS decision →

Related product codes

Other codes under 21 CFR 890.5925.

ILZ Accessories, Traction