510(k) Report

FDA product code · Neurology

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

QGHClass II21 CFR 882.5940510(k) required9 decisions since 19840 recalls

9 FDA decisions since 1984. No recall names this code. The most-cited predicate is K960754, named by 1 later device.

Catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.

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 QGH 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 · QGH

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QGH

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

Recalls per year · QGH

No recall names QGH since 2007.

Adverse event reports per year · QGH

1in 2025

2021: 12022: 162023: 82024: 82025: 1
2007high 16 (2022) · low 0 (2007)2025

MAUDE reports naming product code QGH, 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—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20201—00
20210—01
20220—016
20230—08
20240—08
20250—01
20260—0—
FIG. 1 — QGH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QGH? 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 QGH devices cite most?

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

  • K960754Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp. · 19961cites it
  • K852069Mecta Ect Device Models SR & JRMecta Corp. · 19851cites it

Which QGH devices have the deepest lineage?

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

  • K965070Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp. · 19972generations
  • K960754Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp. · 19961generation

What has FDA decided in QGH lately?

  • K192834MECTA SigmaMecta Corporation · 2020
  • K965070Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp. · 1997
  • K960754Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp. · 1996
  • K945120Thymatron 2000 Electroconvulsive SystemSomatics, Inc. · 1995
  • K911144MF-500, ModificationElcot, Inc. · 1991
  • K863815Electroconvulsive Therapy Device, Model MF-1000Elcot, Inc. · 1987

All 9 QGH decisions →

Related product codes

Other codes under 21 CFR 882.5940.

GXC Device, Electroconvulsive Therapy