510(k) Report

510(k) · Cleared

Cleared

MF-500, Modification

K911144510(k) TraditionalCleared Oct 18, 1991235-day reviewClass II21 CFR 882.5940

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

Elcot, Inc. · QGH Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

Cleared on Oct 18, 1991 after a 235-day review. The FDA summary names no predicate by number.

Decided
Oct 18, 1991
Review
235 days
Class
Class II
Product code
QGH
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K911144Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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

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

Planning a device in QGH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

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 QGH devices

QGH Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Elcot, Inc.

2 FDA decisions under this applicant name. See the company

  • K863815Electroconvulsive Therapy Device, Model MF-1000Elcot, Inc. · 1987

Recent decisions in QGH

The QGH category page

  • 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
  • K863815Electroconvulsive Therapy Device, Model MF-1000Elcot, Inc. · 1987

https://510kreport.com/device/K911144 · printed Nov 6, 2026

Cite this page

510(k) Report. “K911144: MF-500, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911144

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026