Product code LZH
- Device name
- Pump, Infusion, Enteral
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5725
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253558 | Luminoah FLOW™ Enteral Nutrition System | Luminoah | 2026-04-20 |
| K232205 | 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 | Vesco Medical, LLC | 2023-10-23 |
| K221603 | Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spi... | Cardinal Health, LLC | 2022-12-20 |
| K220230 | AMSure Enteral Feeding Pump | Amsino International, Inc. | 2022-11-10 |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | Amsino International, Inc. | 2020-09-25 |
| K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal | Covidien | 2016-07-06 |
| K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | Covidien | 2015-05-29 |
| K141479 | KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS | Covidien | 2014-12-23 |
| K131154 | ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; | Zevex, Inc. | 2014-02-12 |
| K111381 | MEDI-SIS SYRINGE INFUSION SYSTEM | Acacia, Inc. | 2012-01-13 |
| K060316 | COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS | Fresenius Kabi Deutschland GmbH | 2006-06-23 |
| K040957 | NOA III ENTERAL NUTRITION PUMP | Caesarea Medical Electronics , Ltd. | 2004-05-21 |
| K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | Tyco Healthcare/Kendall | 2004-05-05 |
| K031199 | ENTERALITE INFINITY ENTERAL FEEDING PUMP | Zevex Intl., Inc. | 2003-07-09 |
| K031407 | ROSS EMBRACE ENTERAL PUMP | Ross Product Div. Abbott Laboratories | 2003-05-20 |
| K011868 | ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS | Debio Tech SA | 2001-09-04 |
| K003047 | AMBULATORY ENTERAL NUTRITION PUMP | Ross Product Div. Abbott Laboratories | 2001-06-12 |
| K011587 | SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP | Entracon Corp. | 2001-06-01 |
| K981541 | CLEARSTAR ENTERAL NUTRITION PUMP | Frantz Medical Development, Ltd. | 1998-08-13 |
| K954735 | ENTERALITE | Zevex Intl., Inc. | 1996-04-15 |
| K946168 | IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS | Ivac Corporation | 1996-03-21 |
| K951429 | FLEXIFLO 6.1 ENTERAL NUTRITION PUMP | Ross Products | 1995-12-22 |
| K952671 | RATESAVER PLUS | Entracare Corp. | 1995-08-18 |
| K945964 | KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS | Sherwood Medical Co. | 1995-03-07 |
| K940555 | SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION | Sandoz Nutrition | 1995-02-01 |
| K943733 | FLEXIFLO SIX ENTERAL NUTRITION PUMP | Abbott Mfg., Inc. | 1994-12-12 |
| K940556 | SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP | Sandoz Nutrition | 1994-11-07 |
| K923066 | FLO-GARD 2100 - 2M8281M | Baxter Healthcare Corp | 1993-05-13 |
| K914216 | FRENTA II+ ENTERAL FEEDING PUMP | Fresenius Pharma | 1992-03-18 |
| K913958 | FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP | Abbott Laboratories | 1992-02-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10192253009675 | Kangaroo | Cardinal Health 200, LLC | 2026-05-12 |
| 10192253068917 | Kangaroo | Cardinal Health 200, LLC | 2025-09-30 |
| 10192253068900 | Kangaroo | Cardinal Health 200, LLC | 2025-09-30 |
| 10192253011135 | Kangaroo | Cardinal Health 200, LLC | 2025-05-28 |
| 10192253008456 | Kangaroo | Cardinal Health 200, LLC | 2025-05-19 |
| 10192253009965 | Kangaroo | Cardinal Health 200, LLC | 2025-05-02 |
| 10192253009859 | Kangaroo | Cardinal Health 200, LLC | 2025-05-02 |
| 10192253009682 | Kangaroo | Cardinal Health 200, LLC | 2025-05-02 |
| 10192253008418 | Kangaroo | Cardinal Health 200, LLC | 2025-04-29 |
| 10192253008432 | Kangaroo | Cardinal Health 200, LLC | 2025-04-29 |
| 10192253023107 | Kangaroo | Cardinal Health 200, LLC | 2024-12-16 |
| 10192253008159 | Kangaroo | Cardinal Health 200, LLC | 2024-12-16 |
| 10192253008371 | Kangaroo | Cardinal Health 200, LLC | 2024-11-22 |
| 10192253065763 | Kangaroo | Cardinal Health 200, LLC | 2024-11-22 |
| 10192253008395 | Kangaroo | Cardinal Health 200, LLC | 2024-11-22 |
| 10192253008425 | Kangaroo | Cardinal Health 200, LLC | 2024-10-23 |
| 10192253009637 | Kangaroo | Cardinal Health 200, LLC | 2024-09-30 |
| 10192253009613 | Kangaroo | Cardinal Health 200, LLC | 2024-09-30 |
| 10192253009620 | Kangaroo | Cardinal Health 200, LLC | 2024-09-25 |
| 10192253009651 | Kangaroo | Cardinal Health 200, LLC | 2024-09-24 |
| 10192253009989 | Kangaroo | Cardinal Health 200, LLC | 2024-09-23 |
| 10192253007183 | Kangaroo | Cardinal Health 200, LLC | 2024-09-03 |
| 10192253011074 | Kangaroo | Cardinal Health 200, LLC | 2023-10-24 |
| 50885380184152 | Kangaroo | Cardinal Health 200, LLC | 2023-08-29 |
| 10192253009958 | Kangaroo | Cardinal Health 200, LLC | 2023-02-10 |
| 10192253009941 | Kangaroo | Cardinal Health 200, LLC | 2023-02-10 |
| 10192253009903 | Kangaroo | Cardinal Health 200, LLC | 2022-12-06 |
| 10192253009996 | Kangaroo | Cardinal Health 200, LLC | 2022-01-06 |
| 10884521022034 | Kangaroo | Cardinal Health, Inc. | 2016-09-24 |
| 10884521022041 | Kangaroo | Cardinal Health, Inc. | 2016-09-24 |