Ethox Corp.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Ethox Corp.” (first 1977, latest 2004), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 6 | 6 |
| DXQ | Blood Pressure Cuff | 4 | 4 |
| FRN | Pump, Infusion | 3 | 3 |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | 2 | 2 |
| FHT | Set, Gavage, Infant, Sterile | 1 | 1 |
| JXL | Block, Bite | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| KZD | Infusor, Pressure, For I.V. Bags | 1 | 1 |
Review panels
Most recent Ethox Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040286 | ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS | DXQ | 2004-03-15 | 38 |
| K031195 | CUF-COVER (TM) | DXQ | 2003-10-10 | 177 |
| K962850 | TUM-E-VAC | KDH | 1997-02-21 | 214 |
| K935633 | NO-MES | KNT | 1994-09-30 | 311 |
| K921946 | TUM-E-VAC BITE BLOCK | JXL | 1992-12-09 | 226 |
| K885220 | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT | KNT | 1989-09-25 | 279 |
| K894927 | SURGI SQUEEZ | KZD | 1989-09-11 | 40 |
| K883977 | SURGI-CUF STERILE/NON-STERILE DISPOSABLE | DXQ | 1989-02-10 | 143 |
| K860599 | ETHOX LAVAGE TUBE | KDH | 1986-03-11 | 20 |
| K844988 | ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. | DXQ | 1985-04-04 | 99 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ethox 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ethox Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ethox International (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ethox Corp.?
FDA lists 19 510(k) clearances under the applicant name “Ethox Corp.” (first 1977, latest 2004), across 8 product codes in 4 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 Ethox Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ethox Corp. is 40 days.
Which FDA product codes appear under Ethox Corp.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 6); DXQ (Blood Pressure Cuff, 4); FRN (Pump, Infusion, 3).
Next steps
- See all 19 Ethox Corp. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Ethox 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.