Extension Feeding Set with ENFit Connectors
FDA 510(k) K250481 · SKY Medical, a.s.
510(k) numberK250481
Submission
- Device name
- Extension Feeding Set with ENFit Connectors
- Applicant
- SKY Medical, a.s.
Samorin, SK - Received
- February 19, 2025
- Decision date
- April 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PIF – Gastrointestinal Tubes With Enteral Specific Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
To facilitate enteral specific connections.
Other 510(k)s with product code PIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260110 | danumed Extension Set for Gastrostomy ButtonPIF · Traditional | Danumed Medizintechnik GmbH | 09/10/2026SE |
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…PIF · Traditional | Maquet Critical Care AB | 08/26/2026SE |
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) KitPIF · Traditional | Degania Silicone , Ltd. | 03/20/2026SE |
| K242917 | Enteral Drainage System, Enteral Medicine strawPIF · Traditional | HMC Premedical S.p.A. | 06/18/2025SE |
| K240052 | Disposable Enteral Feeding SetsPIF · Traditional | Beijing L&Z Medical Technology Development Co.… | 07/03/2024SE |
| K233034 | Mobility+ Enteral Feeding System OTCPIF · Traditional | Rockfield Medical | 04/12/2024SE |
| K230326 | ENFit to ENFit Extension SetsPIF · Traditional | Vesco Medical | 11/02/2023SE |
| K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT…PIF · Traditional | Xeridiem Medical Devices, A Spectrum Plastics… | 10/06/2023SE |
| K222773 | Feeding TubePIF · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/17/2023SE |
| K223683 | EnteraLoc FlowPIF · Traditional | Vonco Products | 07/10/2023SE |
Questions and answers
When was Extension Feeding Set with ENFit Connectors cleared by the FDA?
Extension Feeding Set with ENFit Connectors (K250481) received a 510(k) decision of Substantially Equivalent on April 18, 2025, 58 days after the submission was received.
What is the product code of K250481?
The FDA product code is PIF – Gastrointestinal Tubes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.