510(k) Report

510(k) · Cleared

Cleared

Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.

K965070510(k) TraditionalCleared Mar 6, 199785-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 Mar 6, 1997 as substantially equivalent to K960754 (Mecta Corp., 1996) after an 85-day review. Its family tree reaches back 2 generations to 1985.

Decided
Mar 6, 1997
Review
85 days
Class
Class II
Product code
QGH
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K852069 (1985). No later device cites it as a predicate yet.

K852069 · Mecta Ect Device Models SR & JR · Mecta Corp. · 1985K960754 · Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M · Mecta Corp. · 19961986198819901992199419961998
K960754 · Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M · Mecta Corp. · 1996K852069 · Mecta Ect Device Models SR & JR · Mecta Corp. · 19850
  1. Root · 2 generations backK852069 Mecta Ect Device Models SR & JRMecta Corp. · 1985
  2. 1 generation backK960754 Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp. · 1996
  3. This deviceK965070 Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K852069Mecta Ect Device Models SR & JRMecta Corp.1985—
−1K960754Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp.1996—
0 (this device)K965070Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp.1997—
FIG. 1 — Lineage of K965070, 1985–1997Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K960754Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M
Summary page 7
…ICH DEVICE HAS BEEN PLACED-Class III REASON FOR PREMARKET MODIFICATION-Device modification which is substantially equivalent to the predicate device - spECTrum 5000/4000 K960754 IDENTIFICATION OF A LEGALLY MARKETED DEVICE TO WHICH CLAIM EQUIVALENCE- MECTA Models 5000 Q, 5000 M, 4000 Q, 4000M (same K# 96075…
Mecta Corp.1996—

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.

What does this lineage say?

  • The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 11.1 years on median.
  • None of the 2 ancestors has a 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—

What is it indicated for?

Treatment of “severe depression® ar "major depressive episcde with melancholia”.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Mecta Corp.

3 FDA decisions under this applicant name. See the company

  • K960754Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp. · 1996
  • K852069Mecta Ect Device Models SR & JRMecta Corp. · 1985

Recent decisions in QGH

The QGH category page

  • K192834MECTA SigmaMecta Corporation · 2020
  • 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

https://510kreport.com/device/K965070 · printed Nov 5, 2026

Cite this page

510(k) Report. “K965070: Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965070

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