510(k) · Cleared

Cleared

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

K960754510(k) TraditionalCleared Sep 18, 1996208-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 Sep 18, 1996 as substantially equivalent to K852069 (Mecta Corp., 1985) after a 208-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided: Sep 18, 1996
Review: 208 days
Class: Class II
Product code: QGH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K852069 (1985). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK852069 Mecta Ect Device Models SR & JRMecta Corp. · 1985
This deviceK960754 Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp. · 1996
Descendant · cites it directly · 0 of its ownK965070 Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp. · 1997

Most influential descendants

Showing 1 of 1 · See all

K965070Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K852069	Mecta Ect Device Models SR & JR	Mecta Corp.	1985	—
0 (this device)	K960754	Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M	Mecta Corp.	1996	—
+1	K965070	Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.	Mecta Corp.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K960754, 1985–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K852069	Mecta Ect Device Models SR & JR Summary page 7 …97035 WL e. CLASS IN WHICH DEVICE HAS BEEN PLACED-ClassIIT-. f. REASON FOR PREMARKET MODIFICATION-New device which is substantially equivalent to the predicate device - K852069 g. IDENTIFICATION OF A LEGALLY MARKETED DEVICE TO WHICH CLAIM EQUIVALENCE- MECTA Models SR JR (same K# 852069) h.NOT APPLICABLE…	Mecta Corp.	1985	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K965070	Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.	Mecta Corp.	1997	0

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?

Its one ancestor has no recall.
Of its descendants, K965070 (Mecta Corp., 1997) has gone furthest, with 0 descendants 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

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	1	—	0
2021	0	—	1
2022	0	—	16
2023	0	—	8
2024	0	—	8
2025	0	—	1
2026	0	—	—

What is it indicated for?

The intended use of the MECTA spECTrum device is solely for the treatment of "severe depression" or "major depressive episode with melancholia". (ref CFR Part 882 Part III). The clinical setting is in hospital ECT suites, Operating Rooms, or on patient wards.

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

https://510kreport.com/device/K960754 · printed Nov 3, 2026

Cite this page

510(k) Report. “K960754: Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K960754

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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