T. G. & E. Medical: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “T. G. & E. Medical” (first 1982, latest 1986), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| KPD | Strip, Temperature, Forehead, Liquid Crystal | 2 | 2 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (3)
- Anesthesiology (1)
Most recent T. G. & E. Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860706 | IV BAND (INTRAVENOUS CATHETER ASSESORY) | KMK | 1986-03-21 | 23 |
| K860261 | CANNULA BAND | CAT | 1986-02-18 | 25 |
| K823221 | ACCA-TEMP SKIN TEMP. VINYL DISC | KPD | 1983-01-12 | 75 |
| K820941 | THERMA-SCAN | — | 1982-06-16 | 71 |
| K813199 | SKIN TEMPERATURE SENSING VINYL STRIP | KPD | 1982-03-05 | 112 |
Recalls
openFDA lists no recalls under a recalling firm named T. G. & E. Medical.
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 T. G. & E. Medical?
FDA lists 5 510(k) clearances under the applicant name “T. G. & E. Medical” (first 1982, latest 1986), across 4 product codes in 2 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 T. G. & E. Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name T. G. & E. Medical is 71 days.
Which FDA product codes appear under T. G. & E. Medical?
The most frequent FDA product codes under this applicant name are KPD (Strip, Temperature, Forehead, Liquid Crystal, 2); CAT (Cannula, Nasal, Oxygen, 1); KMK (Device, Intravascular Catheter Securement, 1).
Next steps
- See all 5 T. G. & E. Medical clearances with predicates and recalls
- Run predicate analysis for product code KPD, T. G. & E. Medical'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.