Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral Delivery Set;
FDA 510(k) K131154 · Zevex, Inc.
510(k) numberK131154
Submission
- Device name
- Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral Delivery Set;
- Applicant
- Zevex, Inc.
Salt Lake City, UT, US - Received
- April 24, 2013
- Decision date
- February 12, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| K253558 | Luminoah FLOW Enteral Nutrition SystemLZH · Traditional | Luminoah | 04/20/2026SE |
| K232205 | Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed…LZH · Traditional | Vesco Medical, LLC | 10/23/2023SE |
| 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 |
| 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 |
|---|---|---|
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…FRN · Special | 10/03/2024SE |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…FRN · Traditional | 05/17/2024SE |
| K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery SetPIF · Traditional | 01/08/2015SE |
| K012147 | Device Modification of Enteral Feeding Sets for Gravity and Pump UseKNT · Special | 11/02/2001SE |
Questions and answers
When was Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral Delivery Set; cleared by the FDA?
Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral Delivery Set; (K131154) received a 510(k) decision of Substantially Equivalent on February 12, 2014, 294 days after the submission was received.
What is the product code of K131154?
The FDA product code is LZH – Pump, Infusion, Enteral, a Class II (moderate risk) device regulated under 21 CFR 880.5725.