Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Degania Silicone , Ltd. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
257 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Degania Silicone , Ltd. | 2026-03-20 | 87 | 0 |
| K233591 | Stylus | Degania Silicone , Ltd. | 2024-05-31 | 205 | 0 |
| K152246 | Aquarius Stoma Measuring Device | Degania Silicone , Ltd. | 2016-06-21 | 316 | 0 |
| K143378 | AQUARIUS Gastrostomy Replacement Tube | Degania Silicone , Ltd. | 2014-12-29 | 34 | 0 |
| K141753 | AQUARIUS NASAL FEEDING TUBE | Degania Silicone , Ltd. | 2014-10-16 | 108 | 0 |
| K141631 | AQUARIUS EXTENSION FEEDING SET | Degania Silicone , Ltd. | 2014-07-28 | 40 | 0 |
| K132686 | AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE | Degania Silicone , Ltd. | 2014-05-12 | 257 | 0 |
| K131020 | TEMPERATURE SENSOR CATHETER | Degania Silicone , Ltd. | 2013-05-09 | 27 | 0 |
| K122030 | LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON | Degania Silicone , Ltd. | 2012-09-05 | 56 | 0 |
| K103371 | COUDE/ OR TIEMANN | Degania Silicone , Ltd. | 2011-03-11 | 114 | 0 |
| K070124 | GASTROSTOMY REPLACEMENT TUBE, MODEL 253 | Degania Silicone , Ltd. | 2007-05-23 | 127 | 0 |
| K063442 | ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE | Degania Silicone , Ltd. | 2007-03-26 | 132 | 25 |
| K981956 | DEGANIA SILICONE IDENTI LOOPS | Degania Silicone , Ltd. | 1998-07-09 | 35 | 0 |
| K971482 | DEGANIA SILICONE SIL-K | Degania Silicone , Ltd. | 1997-06-24 | 64 | 0 |
| K964547 | DEGANIA SILICONE INDENTI LOOPS | Degania Silicone , Ltd. | 1997-01-08 | 56 | 0 |
| K953864 | SILCLEAR TUBING (MODIFICATION) | Degania Silicone , Ltd. | 1995-11-06 | 91 | 0 |
| K943992 | SILCLEAR TUBING | Degania Silicone , Ltd. | 1995-03-16 | 212 | 0 |
| K914701 | SIL-K | Degania Silicone , Ltd. | 1992-01-31 | 105 | 0 |
| K875092 | DEGANIA SILICONE TOURNIQUET | Degania Silicone , Ltd. | 1988-01-07 | 28 | 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