Mecta Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Mecta Corp.” (first 1985, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 207 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 207 |
| 2021 | 1 | 385 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mecta Corp. took a median 296 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 242 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QGH | Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder | 4 | 4 |
| JXL | Block, Bite | 1 | 1 |
Review panels
- Neurology (5)
Most recent Mecta Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium | JXL | 2021-06-04 | 385 |
| K192834 | MECTA Sigma | QGH | 2020-04-26 | 207 |
| K965070 | SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. | QGH | 1997-03-06 | 85 |
| K960754 | SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M | QGH | 1996-09-18 | 208 |
| K852069 | MECTA ECT DEVICE MODELS SR & JR | QGH | 1985-08-09 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Mecta Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Mecta Corp. (3)
- Mecta Corporation (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mecta Corp.?
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Mecta Corp.” (first 1985, latest 2021), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mecta Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mecta Corp. is 207 days.
Which FDA product codes appear under Mecta Corp.?
The most frequent FDA product codes under this applicant name are QGH (Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder, 4); JXL (Block, Bite, 1).
Next steps
- See all 5 Mecta Corp. clearances with predicates and recalls
- Run predicate analysis for product code QGH, Mecta Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.