# Degania Silicone, Ltd.

- Location (FDA's records): Emek Hayarden, IL
- FDA decisions: 19 (1988–2026): 19 510(k) clearances
- Product codes: KNT (7), EZL (3), MDA (2), FPK (2), PIF (2), DXC (2), GAX (1)
- 510(k) review time since 2016: median 205 days, against 103 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 12 (3 its own)
- Recalls linked to its devices: 69 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Applied Medical Technology, Inc.: 1 (https://510kreport.com/company/applied-medical-technology)
- Covidien Lp, Formerly Registered AS Kendall: 1 (https://510kreport.com/company/covidien-lp-formerly-registered-as-kendall)
- Sandoz Nutrition: 1 (https://510kreport.com/company/sandoz-nutrition)
- Applied Medical Technologies: 1 (https://510kreport.com/company/applied-medical-technologies)
- Wilson-Cook Medical, Inc.: 1 (https://510kreport.com/company/wilson-cook-medical)

## Firms that cite its devices most
- Danumed Medizintechnik GmbH: 2 (https://510kreport.com/company/danumed-medizintechnik)
- Vesco Medical, LLC: 1 (https://510kreport.com/company/vesco-medical)
- Covidien: 1 (https://510kreport.com/company/covidien)
- SKY Medical, a.s.: 1 (https://510kreport.com/company/sky-medical)
- Cedic S.R.L.: 1 (https://510kreport.com/company/cedic)
- Nellie Medical, LLC: 1 (https://510kreport.com/company/nellie-medical)
- Dominion Medical Devices, LLC: 1 (https://510kreport.com/company/dominion-medical-devices)
- Kmc Intl. Co.: 1 (https://510kreport.com/company/kmc-intl)

## Its most-cited devices
- K141631: Aquarius Extension Feeding Set (2014), cited by 3
- K063442: All Silicone Foley Catheter, 2-Way, 3-Way, with Temperature Sensor (2007), cited by 2
- K143378: AQUARIUS Gastrostomy Replacement Tube (2014), cited by 1
- K141753: Aquarius Nasal Feeding Tube (2014), cited by 1
- K971482: Degania Silicone Sil-K (1997), cited by 1
- K152246: Aquarius Stoma Measuring Device (2016), cited by 1

## Recent decisions
- K254170: Percutaneous Endoscopic Gastrostomy (PEG) Kit (Mar 20, 2026)
- K233591: Stylus (May 31, 2024)
- K152246: Aquarius Stoma Measuring Device (Jun 21, 2016)
- K143378: AQUARIUS Gastrostomy Replacement Tube (Dec 29, 2014)
- K141753: Aquarius Nasal Feeding Tube (Oct 16, 2014)
- K141631: Aquarius Extension Feeding Set (Jul 28, 2014)
- K132686: Aquarius Low Profile Gastrostomy Feeding Tube (May 12, 2014)
- K131020: Temperature Sensor Catheter (May 9, 2013)

Source page: https://510kreport.com/company/degania-silicone