510(k) Report

510(k) · Cleared

Cleared

MTD Hedrest

K884847510(k) TraditionalCleared Jan 9, 198949-day reviewClass I21 CFR 892.1920

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Composites Horizons, Inc. · IWY Holder, Head, Radiographic

Cleared on Jan 9, 1989 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 9, 1989
Review
49 days
Class
Class I
Product code
IWY
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K884847Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All IWY devices

IWY Holder, Head, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IWY

FDA has decided no IWY device since 2007.

Median 510(k) review, days · IWY

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

Recalls per year · IWY

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IWY

1in 2023

2007: 12008: 22009: 12013: 12017: 12022: 12023: 1
2007high 2 (2008) · low 0 (2010)2025

MAUDE reports naming product code IWY, 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—11
20080—02
20090—01
20100—00
20110—00
20120—00
20130—01
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—01
20230—01
20240—00
20250—00
20260—0—

Recent decisions in IWY

The IWY category page

  • K925705Accurad-200 System & Accurad-300 Plus SystemDenar Corp. · 1992
  • K884493Head Holding Device/Sleep ApneaX-Ray Systems · 1989
  • K864527DuocephGary E. Hall, Dds · 1987
  • K850197Keller Cephalometric DeviceGary D. Keller · 1985
  • K844549Head-Spine Stabilizer HSS-1Imaging Accessories, Inc. · 1985

https://510kreport.com/device/K884847 · printed Nov 4, 2026

Cite this page

510(k) Report. “K884847: MTD Hedrest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K884847

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026