FDA Product Code
FDA Product Code LZH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253558 | Luminoah FLOW Enteral Nutrition System | Luminoah | 2026-04-20 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| 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 Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI | Cardinal Health, LLC | 2022-12-20 | Traditional | PDF ↗ |
| K220230 | AMSure Enteral Feeding Pump | Amsino International, Inc. | 2022-11-10 | Traditional | PDF ↗ |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | Amsino International, Inc. | 2020-09-25 | Traditional | PDF ↗ |
| K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal | Covidien | 2016-07-06 | Traditional | PDF ↗ |
| K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | Covidien | 2015-05-29 | Traditional | PDF ↗ |
| K141479 | KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS | Covidien | 2014-12-23 | Traditional | PDF ↗ |
| K131154 | ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; | Zevex, Inc. | 2014-02-12 | Special | PDF ↗ |
| K111381 | MEDI-SIS SYRINGE INFUSION SYSTEM | Acacia, Inc. | 2012-01-13 | Traditional | PDF ↗ |
| K060316 | COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS | Fresenius Kabi Deutschland GmbH | 2006-06-23 | Traditional | PDF ↗ |
| K040957 | NOA III ENTERAL NUTRITION PUMP | Caesarea Medical Electronics , Ltd. | 2004-05-21 | Traditional | PDF ↗ |
| K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | Tyco Healthcare/Kendall | 2004-05-05 | Traditional | PDF ↗ |
| K031199 | ENTERALITE INFINITY ENTERAL FEEDING PUMP | Zevex Intl., Inc. | 2003-07-09 | Traditional | PDF ↗ |
| K031407 | ROSS EMBRACE ENTERAL PUMP | Ross Product Div. Abbott Laboratories | 2003-05-20 | Special | PDF ↗ |
| K011868 | ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS | Debio Tech SA | 2001-09-04 | Traditional | PDF ↗ |
| K003047 | AMBULATORY ENTERAL NUTRITION PUMP | Ross Product Div. Abbott Laboratories | 2001-06-12 | Traditional | PDF ↗ |
| K011587 | SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP | Entracon Corp. | 2001-06-01 | Traditional | PDF ↗ |
| K981541 | CLEARSTAR ENTERAL NUTRITION PUMP | Frantz Medical Development, Ltd. | 1998-08-13 | Traditional | PDF ↗ |
| K954735 | ENTERALITE | Zevex Intl., Inc. | 1996-04-15 | Traditional | PDF ↗ |
| K946168 | IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS | Ivac Corporation | 1996-03-21 | Traditional | PDF ↗ |
| K951429 | FLEXIFLO 6.1 ENTERAL NUTRITION PUMP | Ross Products | 1995-12-22 | Traditional | PDF ↗ |
| K952671 | RATESAVER PLUS | Entracare Corp. | 1995-08-18 | Traditional | PDF ↗ |
| K945964 | KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS | Sherwood Medical Co. | 1995-03-07 | Traditional | PDF ↗ |
| K940555 | SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION | Sandoz Nutrition | 1995-02-01 | Traditional | PDF ↗ |
| K943733 | FLEXIFLO SIX ENTERAL NUTRITION PUMP | Abbott Mfg., Inc. | 1994-12-12 | Traditional | PDF ↗ |
| K940556 | SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP | Sandoz Nutrition | 1994-11-07 | Traditional | PDF ↗ |
| K923066 | FLO-GARD 2100 - 2M8281M | Baxter Healthcare Corp | 1993-05-13 | Traditional | PDF ↗ |
| K914216 | FRENTA II+ ENTERAL FEEDING PUMP | Fresenius Pharma | 1992-03-18 | Traditional | PDF ↗ |
| K913958 | FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP | Abbott Laboratories | 1992-02-07 | Traditional | PDF ↗ |
| K913413 | KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE | Sherwood Medical Co. | 1991-11-29 | Traditional | PDF ↗ |
| K901458 | NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP | Clinical Systems, Inc. | 1990-06-22 | Traditional | PDF ↗ |
| K891575 | COMPAT ENTERAL FEED PUMP 199235 & 199240 | Sandoz Nutrition | 1989-09-12 | Traditional | PDF ↗ |
| K873119 | FLEXIFLO COMPANION ENTERAL NUTRITION PUMP | Frantz Medical Development, Ltd. | 1987-11-05 | Traditional | PDF ↗ |
Product code LZH · Class II · General Hospital. Data: openFDA.