Degania Silicone , Ltd.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Degania Silicone , Ltd.” (first 1988, latest 2026), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 91 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 | 1 | 56 |
| 2013 | 1 | 27 |
| 2014 | 4 | 74 |
| 2015 | 0 | — |
| 2016 | 1 | 316 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 205 |
| 2025 | 0 | — |
| 2026 | 1 | 87 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Degania Silicone , Ltd. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 7 | 7 |
| EZL | Catheter, Retention Type, Balloon | 3 | 3 |
| DXC | Clamp, Vascular | 2 | 2 |
| FPK | Tubing, Fluid Delivery | 2 | 2 |
| MDA | Elastomer, Silicone, For Scar Management | 2 | 2 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 2 | 2 |
| GAX | Tourniquet, Nonpneumatic | 1 | 1 |
Review panels
- Gastroenterology and Urology (12)
- General and Plastic Surgery (3)
- Cardiovascular (2)
- General Hospital (2)
Most recent Degania Silicone , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | PIF | 2026-03-20 | 87 |
| K233591 | Stylus | KNT | 2024-05-31 | 205 |
| K152246 | Aquarius Stoma Measuring Device | KNT | 2016-06-21 | 316 |
| K143378 | AQUARIUS Gastrostomy Replacement Tube | KNT | 2014-12-29 | 34 |
| K141753 | AQUARIUS NASAL FEEDING TUBE | PIF | 2014-10-16 | 108 |
| K141631 | AQUARIUS EXTENSION FEEDING SET | KNT | 2014-07-28 | 40 |
| K132686 | AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE | KNT | 2014-05-12 | 257 |
| K131020 | TEMPERATURE SENSOR CATHETER | EZL | 2013-05-09 | 27 |
| K122030 | LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON | KNT | 2012-09-05 | 56 |
| K103371 | COUDE/ OR TIEMANN | EZL | 2011-03-11 | 114 |
9 earlier clearances. See the full list in Caduvo.
Recalls
43 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2019-12-02.
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 Degania Silicone , Ltd.?
FDA lists 19 510(k) clearances under the applicant name “Degania Silicone , Ltd.” (first 1988, latest 2026), across 7 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 Degania Silicone , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Degania Silicone , Ltd. is 91 days.
Which FDA product codes appear under Degania Silicone , Ltd.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 7); EZL (Catheter, Retention Type, Balloon, 3); DXC (Clamp, Vascular, 2).
Next steps
- See all 19 Degania Silicone , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Degania Silicone , Ltd.'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.