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

Hospal Medical Corp. — Predicate Candidate Screening

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

43 daysmedian FDA review time

117 days90th percentile

55clearances measured

K-number	Device	Applicant	Decided	Review days
K893742	FILTRAL TM 20 HEMODIALYZER/FILTER	Hospal Medical Corp.	1989-07-24	68
K884365	MULTIFLOW(TM) 60 KIT	Hospal Medical Corp.	1988-12-08	51
K884326	FILTRAL TM 8 HEMODIALYZER	Hospal Medical Corp.	1988-12-05	52
K883307	CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT	Hospal Medical Corp.	1988-10-12	69
K872767	FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER	Hospal Medical Corp.	1987-12-29	168
K871218	MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT	Hospal Medical Corp.	1987-04-30	34
K863961	HOSPAL BIOSPAL 1800S	Hospal Medical Corp.	1986-12-17	68
K863592	DISSCAP 80E, 110E, 140E, 160E	Hospal Medical Corp.	1986-09-25	10
K861156	HOSPAL DIALYSATE FOR CAVHD	Hospal Medical Corp.	1986-09-23	179
K861230	MONITRAL S	Hospal Medical Corp.	1986-04-25	24
K854951	PLUME Y SET	Hospal Medical Corp.	1986-01-08	29
K852885	FILTRAL HEMODIALYZER	Hospal Medical Corp.	1985-09-06	59
K852134	BSM 22 BLOOD SAFETY MODULE	Hospal Medical Corp.	1985-06-12	27
K852135	BSM 21 BLOOD SAFETY MODULE	Hospal Medical Corp.	1985-06-12	27
K852073	VIAL SYRINGE PUMPS, SE200, SE200B & SE400	Hospal Medical Corp.	1985-06-07	25
K851453	HOSPAL FISTULA NEEDLE	Hospal Medical Corp.	1985-04-29	18
K851380	DISSCAP 110 DIALYZER	Hospal Medical Corp.	1985-04-25	17
K850179	MBM(TM) MONITRAL (R) BICARBONATE MODULE	Hospal Medical Corp.	1985-02-28	42
K841791	PLUME FISTULA NEEDLE	Hospal Medical Corp.	1984-07-09	70
K841152	HOSPAL BIOSPAL SCU/CAVH KIT	Hospal Medical Corp.	1984-07-06	109
K840812	BIOSPAL 2400S	Hospal Medical Corp.	1984-04-02	41
K840811	BIOSPAL 3000S	Hospal Medical Corp.	1984-04-02	41
K840814	HOSPAL MODEL H1210	Hospal Medical Corp.	1984-04-02	45
K840813	BIOSPAL 1200S	Hospal Medical Corp.	1984-04-02	45
K834589	BIOSPAL (R) 1800S	Hospal Medical Corp.	1984-02-04	37
K834579	BIOSPAL 2400S	Hospal Medical Corp.	1984-02-04	37
K833440	BLOOD SAFETY MODULE BSM2	Hospal Medical Corp.	1983-12-08	64
K832659	BIOSPAL 1200S	Hospal Medical Corp.	1983-09-20	43
K832645	BIOSPAL 3000 S	Hospal Medical Corp.	1983-09-20	46
K830595	MONITRAL	Hospal Medical Corp.	1983-04-28	63
K830648	H1207	Hospal Medical Corp.	1983-03-29	28
K830647	H1210	Hospal Medical Corp.	1983-03-29	28
K823707	HOSPAL BLOOD LINES	Hospal Medical Corp.	1983-01-05	27
K823589	H 12 07	Hospal Medical Corp.	1982-12-22	16
K822386	COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA	Hospal Medical Corp.	1982-10-06	58
K822851	DISSCAP 080	Hospal Medical Corp.	1982-10-04	10
K820965	DISSCAP 140	Hospal Medical Corp.	1982-04-16	10
K820966	DISSCAP 110	Hospal Medical Corp.	1982-04-16	10
K812575	MODEL H12-10	Hospal Medical Corp.	1981-10-19	40
K802466	DISSCAP HOLLOW FIBER DIALYZER	Hospal Medical Corp.	1980-11-12	35
K800536	MODEL H 607-.67M2 30 MICRON RP AN69 MEM	Hospal Medical Corp.	1980-08-07	150
K800650	MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM	Hospal Medical Corp.	1980-04-02	9
K791489	VITAL CATHETER	Hospal Medical Corp.	1979-10-26	84
K791490	UNIPUNCTURE CATHETER	Hospal Medical Corp.	1979-10-26	84
K790827	RP-610 PARALLEL PLATE DIALYZER	Hospal Medical Corp.	1979-09-04	137
K791448	HEMODIALYZERS RP-510 AND RP-514	Hospal Medical Corp.	1979-08-07	1
K790001	DIALYZER, MODEL F.M.D 150	Hospal Medical Corp.	1979-03-06	63
K780527	CORTRAL I	Hospal Medical Corp.	1978-12-20	261
K781464	HEMODIALYZER, MODEL RP610, RP AN 69	Hospal Medical Corp.	1978-12-20	117
K781142	DISSCAP	Hospal Medical Corp.	1978-09-14	66

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