Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set
FDA 510(k) K232205 · Vesco Medical, LLC
510(k) numberK232205
Submission
- Device name
- Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set
- Applicant
- Vesco Medical, LLC
Westerville, OH, US - Received
- July 25, 2023
- Decision date
- October 23, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZH – Pump, Infusion, Enteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code LZH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253558 | Luminoah FLOW Enteral Nutrition SystemLZH · Traditional | Luminoah | 04/20/2026SE |
| K221603 | Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD…LZH · Traditional | Cardinal Health, LLC | 12/20/2022SE |
| K220230 | AMSure Enteral Feeding PumpLZH · Traditional | Amsino International, Inc. | 11/10/2022SE |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding SetLZH · Traditional | Amsino International, Inc. | 09/25/2020SE |
| K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…LZH · Traditional | Covidien | 07/06/2016SE |
| K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding SetsLZH · Traditional | Covidien | 05/29/2015SE |
| K141479 | Kangaroo Enteral Feeding Set with Enfit ConnectorsLZH · Traditional | Covidien | 12/23/2014SE |
| K131154 | Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral…LZH · Special | Zevex, Inc. | 02/12/2014SE |
| K111381 | Medi-Sis Syringe Infusion SystemLZH · Traditional | Acacia, Inc. | 01/13/2012SE |
| K060316 | Compat Go Enteral Feeding Pump and Administration SetsLZH · Traditional | Fresenius Kabi Deutschland GmbH | 06/23/2006SE |
More from Fresenius Kabi Deutschland GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K230326 | ENFit to ENFit Extension SetsPIF · Traditional | 11/02/2023SE |
| K192991 | Vesco Medical Extension Feeding SetPIF · Traditional | 08/03/2020SE |
| K170162 | Vesco Medical Nasoenteric Feeding TubesPIF · Traditional | 09/26/2017SE |
| K170218 | Vesco Medical NRFit Tip SyringesFMF · Traditional | 02/24/2017SE |
Questions and answers
When was Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set cleared by the FDA?
Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set (K232205) received a 510(k) decision of Substantially Equivalent on October 23, 2023, 90 days after the submission was received.
What is the product code of K232205?
The FDA product code is LZH – Pump, Infusion, Enteral, a Class II (moderate risk) device regulated under 21 CFR 880.5725.