Teca, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Teca, Inc.” (first 1976, latest 1996), across 14 product codes in 5 review panels. Median 510(k) review time under this name: 83 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 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | 5 | 5 |
| GWE | Stimulator, Photic, Evoked Response | 4 | 4 |
| GWF | Stimulator, Electrical, Evoked Response | 4 | 4 |
| GWJ | Stimulator, Auditory, Evoked Response | 3 | 3 |
| IKN | Electromyograph, Diagnostic | 3 | 3 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 2 | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| ETS | Generator, Electronic Noise (For Audiometric Testing) | 1 | 1 |
| GWN | Nystagmograph | 1 | 1 |
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | 1 | 1 |
Plus 4 more product codes.
Review panels
- Neurology (25)
- Cardiovascular (1)
- Ear, Nose and Throat (1)
- Physical Medicine (1)
- Radiology (1)
Most recent Teca, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962283 | EEG ELECTRODES | GXY | 1996-12-16 | 186 |
| K903731 | SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME | GWF | 1991-02-04 | 172 |
| K903004 | EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH | GWQ | 1990-11-15 | 129 |
| K896666 | P460, DG32 ELECTROENCEPHALOGRAPH | GWQ | 1990-02-16 | 81 |
| K894889 | TECA NEUROMAPPER 386 | OLT | 1989-12-22 | 143 |
| K894088 | TECA NEUROMAPPER 1620, BRAIN MAPPER | OLT | 1989-11-15 | 160 |
| K890881 | TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS | GWQ | 1989-03-23 | 30 |
| K884870 | TECA/MEDELEC 'CONCEPT' P420 | GWF | 1989-02-23 | 94 |
| K880593 | TECA/MEDELEC MISTRAL | GWE | 1988-04-06 | 55 |
| K872931 | TECA/MEDELEC TTT THERMAL THRESHOLD TESTER | LLN | 1987-11-16 | 112 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Teca, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Teca, Inc.?
FDA lists 29 510(k) clearances under the applicant name “Teca, Inc.” (first 1976, latest 1996), across 14 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Teca, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Teca, Inc. is 83 days.
Which FDA product codes appear under Teca, Inc.?
The most frequent FDA product codes under this applicant name are GWQ (Full-Montage Standard Electroencephalograph, 5); GWE (Stimulator, Photic, Evoked Response, 4); GWF (Stimulator, Electrical, Evoked Response, 4).
Next steps
- See all 29 Teca, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWQ, Teca, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.