Disposable Enteral Feeding Sets

FDA 510(k) K240052 · Beijing L&Z Medical Technology Development Co., Ltd.

Substantially Equivalent

510(k) numberK240052

Submission

Device name
Disposable Enteral Feeding Sets
Applicant
Beijing L&Z Medical Technology Development Co., Ltd.
Beijing, CN
Received
January 8, 2024
Decision date
July 3, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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)DeviceApplicantDecision
K260110danumed Extension Set for Gastrostomy ButtonPIF · Traditional Danumed Medizintechnik GmbH09/10/2026SE
K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…PIF · Traditional Maquet Critical Care AB08/26/2026SE
K254170Percutaneous Endoscopic Gastrostomy (PEG) KitPIF · Traditional Degania Silicone , Ltd.03/20/2026SE
K242917Enteral Drainage System, Enteral Medicine strawPIF · Traditional HMC Premedical S.p.A.06/18/2025SE
K250481Extension Feeding Set with ENFit™ ConnectorsPIF · Traditional SKY Medical, a.s.04/18/2025SE
K233034Mobility+ Enteral Feeding System OTCPIF · Traditional Rockfield Medical04/12/2024SE
K230326ENFit to ENFit Extension SetsPIF · Traditional Vesco Medical11/02/2023SE
K232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT…PIF · Traditional Xeridiem Medical Devices, A Spectrum Plastics…10/06/2023SE
K222773Feeding TubePIF · Traditional Anhui Tiankang Medical Technology Co., Ltd.08/17/2023SE
K223683EnteraLoc FlowPIF · Traditional Vonco Products07/10/2023SE

More from Vonco Products

510(k)DeviceDecision
K252079Disposable Infusion Bag for Parenteral NutritionKPE · Traditional 04/02/2026SE
K222622Disposable Infusion Bag for Parenteral NutritionKPE · Traditional 02/16/2023SE

Questions and answers

When was Disposable Enteral Feeding Sets cleared by the FDA?

Disposable Enteral Feeding Sets (K240052) received a 510(k) decision of Substantially Equivalent on July 3, 2024, 177 days after the submission was received.

What is the product code of K240052?

The FDA product code is PIF – Gastrointestinal Tubes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.