Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LZH — Predicate Candidate Screening

34 FDA 510(k) clearances under this product code; the 50 most recent screened below.

176 daysmedian FDA review time

294 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253558	Luminoah FLOW™ Enteral Nutrition System	Luminoah	2026-04-20	154	0
K232205	Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set;	Vesco Medical, LLC	2023-10-23	90	0
K221603	Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™	Cardinal Health, LLC	2022-12-20	201	0
K220230	AMSure Enteral Feeding Pump	Amsino International, Inc.	2022-11-10	287	0
K200051	PUGGLE Enteral Feeding Pump and Feeding Set	Amsino International, Inc.	2020-09-25	259	0
K153074	Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect	Covidien	2016-07-06	258	0
K143263	Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect	Covidien	2015-05-29	197	0
K141479	KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS	Covidien	2014-12-23	202	0
K131154	ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE I	Zevex, Inc.	2014-02-12	294	0
K111381	MEDI-SIS SYRINGE INFUSION SYSTEM	Acacia, Inc.	2012-01-13	241	0
K060316	COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS	Fresenius Kabi Deutschland GmbH	2006-06-23	135	0
K040957	NOA III ENTERAL NUTRITION PUMP	Caesarea Medical Electronics , Ltd.	2004-05-21	38	0
K040196	KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS	Tyco Healthcare/Kendall	2004-05-05	97	0
K031199	ENTERALITE INFINITY ENTERAL FEEDING PUMP	Zevex Intl., Inc.	2003-07-09	86	4
K031407	ROSS EMBRACE ENTERAL PUMP	Ross Product Div. Abbott Laboratories	2003-05-20	15	1
K011868	ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS	Debio Tech SA	2001-09-04	82	0
K003047	AMBULATORY ENTERAL NUTRITION PUMP	Ross Product Div. Abbott Laboratories	2001-06-12	256	0
K011587	SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP	Entracon Corp.	2001-06-01	9	0
K981541	CLEARSTAR ENTERAL NUTRITION PUMP	Frantz Medical Development, Ltd.	1998-08-13	106	1
K954735	ENTERALITE	Zevex Intl., Inc.	1996-04-15	182	0
K946168	IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS	Ivac Corporation	1996-03-21	458	0
K951429	FLEXIFLO 6.1 ENTERAL NUTRITION PUMP	Ross Products	1995-12-22	269	0
K952671	RATESAVER PLUS	Entracare Corp.	1995-08-18	67	0
K945964	KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS	Sherwood Medical Co.	1995-03-07	90	0
K940555	SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION	Sandoz Nutrition	1995-02-01	359	1
K943733	FLEXIFLO SIX ENTERAL NUTRITION PUMP	Abbott Mfg., Inc.	1994-12-12	132	0
K940556	SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP	Sandoz Nutrition	1994-11-07	273	2
K923066	FLO-GARD 2100 - 2M8281M	Baxter Healthcare Corp	1993-05-13	322	0
K914216	FRENTA II+ ENTERAL FEEDING PUMP	Fresenius Pharma	1992-03-18	181	0
K913958	FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP	Abbott Laboratories	1992-02-07	155	1
K913413	KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE	Sherwood Medical Co.	1991-11-29	121	0
K901458	NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP	Clinical Systems, Inc.	1990-06-22	86	0
K891575	COMPAT ENTERAL FEED PUMP 199235 & 199240	Sandoz Nutrition	1989-09-12	176	0
K873119	FLEXIFLO COMPANION ENTERAL NUTRITION PUMP	Frantz Medical Development, Ltd.	1987-11-05	87	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda