Atlas FDA

LZH

34 FDA 510(k) clearances · Product code

176 daysmedian time to decision
294 days90th percentile
34clearances measured

FDA profile

Official device name
Pump, Infusion, Enteral
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 1,218 · 2022: 526 · 2023: 284 · 2024: 319 · 2025: 378 · 2026: 174
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Luminoah FLOW™ Enteral Nutrition System (K253558)Luminoah2026-04-20
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)Vesco Medical, LLC2023-10-23
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™ (K221603)Cardinal Health, LLC2022-12-20
AMSure Enteral Feeding Pump (K220230)Amsino International, Inc.2022-11-10
PUGGLE Enteral Feeding Pump and Feeding Set (K200051)Amsino International, Inc.2020-09-25
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal (K153074)Covidien2016-07-06
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets (K143263)Covidien2015-05-29
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS (K141479)Covidien2014-12-23
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; (K131154)Zevex, Inc.2014-02-12
MEDI-SIS SYRINGE INFUSION SYSTEM (K111381)Acacia, Inc.2012-01-13
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS (K060316)Fresenius Kabi Deutschland GmbH2006-06-23
NOA III ENTERAL NUTRITION PUMP (K040957)Caesarea Medical Electronics , Ltd.2004-05-21
KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS (K040196)Tyco Healthcare/Kendall2004-05-05
ENTERALITE INFINITY ENTERAL FEEDING PUMP (K031199)Zevex Intl., Inc.2003-07-09
ROSS EMBRACE ENTERAL PUMP (K031407)Ross Product Div. Abbott Laboratories2003-05-20
ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS (K011868)Debio Tech SA2001-09-04
AMBULATORY ENTERAL NUTRITION PUMP (K003047)Ross Product Div. Abbott Laboratories2001-06-12
SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP (K011587)Entracon Corp.2001-06-01
CLEARSTAR ENTERAL NUTRITION PUMP (K981541)Frantz Medical Development, Ltd.1998-08-13
ENTERALITE (K954735)Zevex Intl., Inc.1996-04-15
IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS (K946168)Ivac Corporation1996-03-21
FLEXIFLO 6.1 ENTERAL NUTRITION PUMP (K951429)Ross Products1995-12-22
RATESAVER PLUS (K952671)Entracare Corp.1995-08-18
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS (K945964)Sherwood Medical Co.1995-03-07
SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION (K940555)Sandoz Nutrition1995-02-01
FLEXIFLO SIX ENTERAL NUTRITION PUMP (K943733)Abbott Mfg., Inc.1994-12-12
SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP (K940556)Sandoz Nutrition1994-11-07
FLO-GARD 2100 - 2M8281M (K923066)Baxter Healthcare Corp1993-05-13
FRENTA II+ ENTERAL FEEDING PUMP (K914216)Fresenius Pharma1992-03-18
FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP (K913958)Abbott Laboratories1992-02-07
KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE (K913413)Sherwood Medical Co.1991-11-29
NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP (K901458)Clinical Systems, Inc.1990-06-22
COMPAT ENTERAL FEED PUMP 199235 & 199240 (K891575)Sandoz Nutrition1989-09-12
FLEXIFLO COMPANION ENTERAL NUTRITION PUMP (K873119)Frantz Medical Development, Ltd.1987-11-05

Track LZH automatically

Every clearance here is in the API, with alerts when new ones post.