510(k) Report

FDA applicant

Mecta Corp.

Lake Oswego, OR5 decisions1985–20210 recalls

FDA records 5 decisions for Mecta Corp. (Lake Oswego, OR) from 1985 to 2021: 5 510(k) clearances. Most are in product codes QGH (Electroconvulsive Therapy Device For…) and JXL (Block, Bite). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Mecta Corporation”.

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

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Mecta Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020: 12021: 1
2007high 1 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mecta Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mecta Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar…4decisions
  • JXLBlock, Bite1decision

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices 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

What has FDA decided for it lately?

  • K201309ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta Corporation · 2021
  • 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
  • K852069Mecta Ect Device Models SR & JRMecta Corp. · 1985

All 3 as Mecta Corp. →All 2 as Mecta Corporation →