Metatech Corp.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Metatech Corp.” (first 1985, latest 2004), across 7 product codes in 6 review panels. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | 5 | 5 |
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| IPL | Wheelchair, Standup | 1 | 1 |
| KPN | Alarm, Conditioned Response Enuresis | 1 | 1 |
Review panels
- Neurology (5)
- General and Plastic Surgery (4)
- General Hospital (3)
- Cardiovascular (2)
- Gastroenterology and Urology (1)
- Physical Medicine (1)
Most recent Metatech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033077 | EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021 | FLL | 2004-04-30 | 214 |
| K033082 | 9 SECOND DIGITAL THERMOMETER, MODEL BT-S09 | FLL | 2003-12-03 | 65 |
| K020520 | EASYTEM EAR THERMOMETER, MODEL BT-020 | FLL | 2002-08-06 | 168 |
| K924314 | MOBILE STANDING FRAME | IPL | 1993-02-12 | 170 |
| K915370 | COPPER VAPOR LASER SYSTEM | GEX | 1992-02-07 | 72 |
| K903883 | VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES | GEX | 1990-09-19 | 28 |
| K890865 | HEXASCAN SCANNER HANDPIECE | GEX | 1989-03-24 | 31 |
| K883541 | METALASER VASCULASE | GEX | 1988-11-04 | 77 |
| K883881 | MODIFIED MODEL 2001 FIBER OPTICS CATHETER | GWM | 1988-10-27 | 90 |
| K883518 | EVENT MARKER & A SECOND PRESSURE TREND OUTPUT | GWM | 1988-09-22 | 37 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Metatech 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Metatech Corp.?
FDA lists 16 510(k) clearances under the applicant name “Metatech Corp.” (first 1985, latest 2004), across 7 product codes in 6 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 Metatech Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Metatech Corp. is 76 days.
Which FDA product codes appear under Metatech Corp.?
The most frequent FDA product codes under this applicant name are GWM (Device, Monitoring, Intracranial Pressure, 5); GEX (Powered Laser Surgical Instrument, 4); FLL (Continuous Measurement Thermometer, 3).
Next steps
- See all 16 Metatech Corp. clearances with predicates and recalls
- Run predicate analysis for product code GWM, Metatech 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, 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.