Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Gambro, Inc. — Predicate Candidate Screening

86 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

44 daysmedian FDA review time

177 days90th percentile

86clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K083158	EXALIS, SOFTWARE VERSION 1.15	Gambro, Inc.	2009-06-05	224	0
K070643	PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35	Gambro, Inc.	2007-11-02	239	0
K032431	PRISMA M60/M100 SETS	Gambro, Inc.	2003-09-15	40	6
K896758	GAMBRO BICARBONATE MONITOR BCM 10-3	Gambro, Inc.	1990-09-28	301	0
K896757	GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS	Gambro, Inc.	1990-08-30	272	0
K902481	GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER	Gambro, Inc.	1990-07-27	52	0
K900918	GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER	Gambro, Inc.	1990-07-16	139	0
K892523	GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY	Gambro, Inc.	1989-05-11	30	0
K890112	ENGSTROM ELIZA + CO2 ANALYZER	Gambro, Inc.	1989-03-15	63	0
K890111	GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER	Gambro, Inc.	1989-02-08	28	0
K883589	GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER	Gambro, Inc.	1988-09-29	38	0
K881270	GAMBRO MULTIPURPOSE SYSTEM MPS-10	Gambro, Inc.	1988-08-24	153	0
K872482	GAMBRO-ENGSTROM ERICA IV RESPIRATOR	Gambro, Inc.	1988-03-03	254	0
K880084	GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS	Gambro, Inc.	1988-02-19	38	0
K880083	GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS	Gambro, Inc.	1988-01-27	15	0
K873643	GAMBRO ADSORBA 150C	Gambro, Inc.	1987-12-29	111	0
K873155	GAMBRO BICART SYSTEM	Gambro, Inc.	1987-10-26	77	0
K871108	GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER	Gambro, Inc.	1987-05-15	57	0
K864095	ENGSTROM EDITH MODELS 500,1000,1500 & 1500F	Gambro, Inc.	1987-02-20	122	0
K864094	GAMBRO FLUID CONTROL MONITOR FCM 10-1	Gambro, Inc.	1986-11-07	17	0
K864083	GAMBRO BICARBONATE MONITOR BCM 10-2	Gambro, Inc.	1986-11-06	17	0
K862840	GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N	Gambro, Inc.	1986-09-29	62	0
K862716	HEMOFILTRATION SYSTEM 10	Gambro, Inc.	1986-09-09	54	0
K860682	GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET	Gambro, Inc.	1986-08-29	185	0
K862025	ENGSTROM ERICA II RESPIRATOR	Gambro, Inc.	1986-06-18	21	0
K860076	GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200	Gambro, Inc.	1986-05-30	142	0
K860938	GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS	Gambro, Inc.	1986-04-07	26	0
K853406	GAMBRO LUNDIA PRO 3 & 5 DIALYZER	Gambro, Inc.	1986-01-08	149	0
K854309	GAMBRO BLOOD CONCENTRATOR SETS 16,60,200	Gambro, Inc.	1985-12-13	49	0
K852455	GAMBRO DIGITAL TELETHERMOMETER TTH 10-200	Gambro, Inc.	1985-09-16	98	0
K852454	CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM	Gambro, Inc.	1985-08-16	67	0
K850621	GAMBRO PLASMAFILTRATION SYSTEM	Gambro, Inc.	1985-05-16	90	0
K851230	GAMBRO PRESSURE MONITOR GUARDS	Gambro, Inc.	1985-04-09	14	0
K842503	GAMBRO PULSATILE MONITOR PLM 10-200	Gambro, Inc.	1984-08-10	45	0
K831404	BLOOD MONITOR BMM 10-4	Gambro, Inc.	1984-04-25	359	0
K840720	FIBER HEMOFILTERS FH55-FH77 & 88	Gambro, Inc.	1984-04-24	67	0
K840645	ENGSTROM ELIZA DUO CO2 & O2 ANALYZ	Gambro, Inc.	1984-04-05	50	0
K840543	BLOOD CONCENTRATOR 140	Gambro, Inc.	1984-03-23	44	0
K831784	HEMOFILTRATION SYSTEM	Gambro, Inc.	1984-02-04	247	0
K832894	LUNDIA 10-2-L PARALLEL PLATE HEMODIALY	Gambro, Inc.	1983-10-14	49	0
K831677	HYPER-HYPOTHERMIA UNIT HYPO 10-200	Gambro, Inc.	1983-07-18	56	0
K831606	GF-180-L HOLLOW FIBER HEMODIALYSIS	Gambro, Inc.	1983-06-24	37	0
K830673	CRAFON ARTHROSCOPY LINES	Gambro, Inc.	1983-06-08	96	0
K831338	LUNDIA 10-3-L PARALLEL FLOW DIALYZER	Gambro, Inc.	1983-05-27	32	0
K830596	ULTRAFILTRATION MONITOR UFM-10-2	Gambro, Inc.	1983-04-27	62	0
K830677	BLOOD LINE SETS FOR HEMOFILTRATION	Gambro, Inc.	1983-04-12	39	0
K830905	LUNDIA 10-2-N PARALLEL FLOW DIALYZER	Gambro, Inc.	1983-04-06	16	0
K823848	CRAFTON ARTHROSCOPY PUMP AP-10	Gambro, Inc.	1983-03-08	77	0
K830284	FH 101, FH 202 & FH 303 FIBER HEMOFILTER	Gambro, Inc.	1983-03-02	34	0
K823791	LUNDIA 10-5-L PARRALLE FLOW DIALYZER	Gambro, Inc.	1983-01-12	27	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