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

Critikon Company, LLC — Predicate Candidate Screening

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

77 daysmedian FDA review time

217 days90th percentile

51clearances measured

K-number	Device	Applicant	Decided	Review days
K002248	DINAMAP PRO 1000 MONITOR, MODEL 1000	Critikon Company, LLC	2000-09-21	58
K000500	DINAMAP ADVANCED NIBP MODULE	Critikon Company, LLC	2000-05-26	102
K992638	DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400	Critikon Company, LLC	2000-02-24	202
K982342	DINAMAP MPS SELECT PORTABLE MONITOR	Critikon Company, LLC	1998-08-14	39
K943709	DINAMAP PLUS VITAL SIGNS MONOITOR	Critikon Company, LLC	1995-06-16	319
K942700	DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340	Critikon Company, LLC	1995-03-01	266
K933404	CRITIKON CENTRAL STATIN MONITOR	Critikon Company, LLC	1994-02-09	212
K933050	CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH	Critikon Company, LLC	1993-12-14	208
K915697	CRITIKON VITAL SIGNS MODULE	Critikon Company, LLC	1993-07-01	556
K921295	INTRAVENOUS CATHETERS MODIFICATIONS	Critikon Company, LLC	1993-05-17	431
K912188	DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700	Critikon Company, LLC	1991-12-04	201
K911769	RATEMINDER(TM) V INFUSION PUMP, MODIFICATION	Critikon Company, LLC	1991-06-03	45
K902092	RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY	Critikon Company, LLC	1990-07-26	78
K894100	OXYTRAK(TM) PULSE OXIMETER	Critikon Company, LLC	1990-05-09	334
K893546	OPTICALLY CLEAR RADIOPAQUE CATHETER	Critikon Company, LLC	1989-11-01	174
K874546	SIM MODULE	Critikon Company, LLC	1988-05-11	190
K875174	RATEMINDER V INFUSION PUMP	Critikon Company, LLC	1988-03-29	103
K874442	DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER	Critikon Company, LLC	1988-02-18	113
K875177	J&J SCALP VEIN INFUSION SETS	Critikon Company, LLC	1988-01-14	23
K874378	DINAMAP VITAL SIGNS MONITOR, MODEL 8100T	Critikon Company, LLC	1987-12-30	65
K873729	RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET	Critikon Company, LLC	1987-12-29	105
K871418	VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200)	Critikon Company, LLC	1987-07-29	112
K861644	CRITIKON 48-HOUR AIR ELIMINATING FILTER	Critikon Company, LLC	1986-07-22	83
K854434	DINAMAP VITAL SIGNS MONITOR MODEL 8100	Critikon Company, LLC	1986-05-16	192
K853701	JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL	Critikon Company, LLC	1985-10-17	43
K844116	CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC	Critikon Company, LLC	1985-05-28	217
K844839	DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX	Critikon Company, LLC	1985-04-01	110
K850507	CRITIKON I.V. ADMINISTRAION SET	Critikon Company, LLC	1985-03-07	27
K843141	CRITIKON HEPARIN-COATED CARDIOVASCULAR	Critikon Company, LLC	1984-09-04	26
K842316	CRITIKON TRIPLE-LUMEN CENTRAL VENOUS	Critikon Company, LLC	1984-07-20	38
K842075	CRITIKON I.V. FILTER	Critikon Company, LLC	1984-06-28	36
K833939	NITROGLYCERIN I.V. ADMINISTRATION SET	Critikon Company, LLC	1984-02-21	98
K833572	HEPARIN-COATED BALLOON THERMODILUT	Critikon Company, LLC	1984-01-30	110
K833918	INFUSION PORT BALLOON THERMODILUTION	Critikon Company, LLC	1984-01-30	77
K832916	INIVOX ELECTRODE/CATHETER SYS	Critikon Company, LLC	1983-11-14	77
K832656	DINAMAP VITAL SIGNS MONITOR #1846P	Critikon Company, LLC	1983-11-07	91
K831967	CRITIKON CARDIAC OUTPUT COMPUTER	Critikon Company, LLC	1983-10-28	130
K831761	SIMPLICITY PLUS	Critikon Company, LLC	1983-08-12	72
K831515	DINAMAP VITAL SIGNS MONITOR #1846	Critikon Company, LLC	1983-06-30	49
K830972	I.V. CATHETER PLACEMENT UNIT POLYURETH	Critikon Company, LLC	1983-04-27	30
K823433	BALLOON THERMODILUTION CATHETER #7164&	Critikon Company, LLC	1982-11-30	14
K821936	CRITIKON OXYGEN MONITOR, MODEL 8030	Critikon Company, LLC	1982-08-16	48
K821890	CRITIKON #817 ESOPHAGEAL MULTI-PROBE	Critikon Company, LLC	1982-08-03	39
K813347	CRITIKON TRANSCUTANEOUS GAS MONITORS	Critikon Company, LLC	1982-01-26	60
K813527	DINAMAP ADULT/PED./NEONATAL VITAL SIGNS	Critikon Company, LLC	1982-01-12	27
K813345	CRITIKON I.V. CATHETER PLACEMENT UNIT	Critikon Company, LLC	1982-01-12	48
K811107	IV SETS	Critikon Company, LLC	1981-06-12	50
K803078	SIMPLICITY INFUSION PUMP MODEL 2100A	Critikon Company, LLC	1981-01-28	54
K801546	THE SIMPLICITY PUMP #2100 INFUSION PUMP	Critikon Company, LLC	1980-08-27	51
K792105	CRITIKON DUAL CHANNEL RECORDER	Critikon Company, LLC	1979-10-26	4

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