510(k) Report

510(k) · Cleared

Cleared

Grieshaber Three Function Manipulator

K914586510(k) TraditionalCleared Jan 3, 199279-day reviewClass I21 CFR 874.4350

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

Grieshaber & Co. · EQH Source, Carrier, Fiberoptic Light

Cleared on Jan 3, 1992 after a 79-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jan 3, 1992
Review
79 days
Class
Class I
Product code
EQH
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K914586Source: 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 lists a 510(k) statement for it but has not posted the file, 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 EQH devices

EQH Source, Carrier, Fiberoptic Light: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EQH

FDA has decided no EQH device since 2007.

Median 510(k) review, days · EQH

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

Recalls per year · EQH

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 · EQH

2in 2024

2008: 22009: 22010: 22011: 12012: 22013: 22014: 12015: 12016: 22017: 32019: 12021: 12022: 12024: 2
2007high 3 (2017) · low 0 (2007)2025

MAUDE reports naming product code EQH, 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—10
20080—02
20090—02
20100—02
20110—01
20120—02
20130—02
20140—01
20150—01
20160—02
20170—03
20180—00
20190—01
20200—00
20210—01
20220—01
20230—00
20240—02
20250—00
20260—0—
Cite this page

510(k) Report. “K914586: Grieshaber Three Function Manipulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K914586

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