Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ethox Corp. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
279 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040286 | ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS | Ethox Corp. | 2004-03-15 | 38 | 0 |
| K031195 | CUF-COVER (TM) | Ethox Corp. | 2003-10-10 | 177 | 0 |
| K962850 | TUM-E-VAC | Ethox Corp. | 1997-02-21 | 214 | 0 |
| K935633 | NO-MES | Ethox Corp. | 1994-09-30 | 311 | 0 |
| K921946 | TUM-E-VAC BITE BLOCK | Ethox Corp. | 1992-12-09 | 226 | 0 |
| K885220 | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT | Ethox Corp. | 1989-09-25 | 279 | 0 |
| K894927 | SURGI SQUEEZ | Ethox Corp. | 1989-09-11 | 40 | 0 |
| K883977 | SURGI-CUF STERILE/NON-STERILE DISPOSABLE | Ethox Corp. | 1989-02-10 | 143 | 0 |
| K860599 | ETHOX LAVAGE TUBE | Ethox Corp. | 1986-03-11 | 20 | 0 |
| K844988 | ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. | Ethox Corp. | 1985-04-04 | 99 | 0 |
| K841512 | ETHOX RELIA-FLO 2001 ENTERAL FEED | Ethox Corp. | 1984-05-21 | 39 | 0 |
| K841014 | WEIGHTED FEEDING TUBE W/PRE-INSERTED | Ethox Corp. | 1984-05-01 | 53 | 0 |
| K834554 | ETHOX WEIGHTED FEEDING TUBE | Ethox Corp. | 1984-02-10 | 45 | 0 |
| K821148 | ETHOX FOOD PUMP STAND W/POLE CLAMP | Ethox Corp. | 1982-05-05 | 12 | 0 |
| K812648 | EHTOX GASTRIC LAVAGE KIT #2050 & #2070 | Ethox Corp. | 1981-09-29 | 12 | 1 |
| K811639 | ETHIX FEEDING TUBES POLYURETHANE/RADIOP. | Ethox Corp. | 1981-06-26 | 16 | 0 |
| K803190 | ETHOX/BARRON #2000 FOOD PUMP-ENTERAL FED | Ethox Corp. | 1981-01-09 | 24 | 0 |
| K801144 | ETHOX/BARRON FOOD PUMP GAVAGE BAG SETS | Ethox Corp. | 1980-06-09 | 27 | 0 |
| K770590 | SURGI-KIT | Ethox Corp. | 1977-04-14 | 17 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda