510(k) Report

510(k) · Cleared

Cleared

Mecta Ect Device Models SR & JR

K852069510(k) TraditionalCleared Aug 9, 198591-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

Mecta Corp. · QGH Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

Cleared on Aug 9, 1985 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Aug 9, 1985
Review
91 days
Class
Class II
Product code
QGH
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1997: 1 descendant cleared1990200020102020
  1. This deviceK852069 Mecta Ect Device Models SR & JRMecta Corp. · 1985
  2. Descendant · cites it directly · 1 of its ownK960754 Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp. · 1996
  3. Descendant · 2 generations on · 0 of its ownK965070 Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp. · 1997

Most influential descendants

Showing 2 of 2 · See all
  • K960754Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp. · 1996 · cites it directly1descendant
  • K965070Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp. · 1997 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K852069Mecta Ect Device Models SR & JRMecta Corp.1985—
+1K960754Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp.1996—
+2K965070Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
FIG. 1 — Lineage of K852069, 1985–1997Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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?

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

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960754Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp.19961

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.

What does this lineage say?

  • Of its descendants, K960754 (Mecta Corp., 1996) has gone furthest, with 1 descendant of its own.

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 Mecta Corp.

3 FDA decisions under this applicant name. See the company

  • K965070Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp. · 1997
  • K960754Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp. · 1996

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
  • K911144MF-500, ModificationElcot, Inc. · 1991

https://510kreport.com/device/K852069 · printed Nov 4, 2026

Cite this page

510(k) Report. “K852069: Mecta Ect Device Models SR & JR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K852069

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026