Critikon Company, LLC
Tampa, FL, US
Critikon Company, LLC appears in FDA device records in Tampa, FL. FDA records list 51 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 51
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 51FDA records hold 51 510(k) clearances for Critikon Company, LLC between 1979 and 2000. The busiest year on record is 1982, with 6. The most recent is 2000, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 2 |
| 1980 | 1 |
| 1981 | 2 |
| 1982 | 6 |
| 1983 | 6 |
| 1984 | 6 |
| 1985 | 4 |
| 1986 | 2 |
| 1987 | 3 |
| 1988 | 4 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 2 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 2 |
| 1998 | 1 |
| 2000 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K002248 | DINAMAP PRO 1000 MONITOR, MODEL 1000 | DXN | Substantially Equivalent | |
| K000500 | DINAMAP ADVANCED NIBP MODULE | DXN | Substantially Equivalent | |
| K992638 | DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 | MWI | Substantially Equivalent | |
| K982342 | DINAMAP MPS SELECT PORTABLE MONITOR | MSX | Substantially Equivalent | |
| K943709 | DINAMAP PLUS VITAL SIGNS MONOITOR | DPS | Substantially Equivalent | |
| K942700 | DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 | MHX | Substantially Equivalent | |
| K933404 | CRITIKON CENTRAL STATIN MONITOR | DPS | Substantially Equivalent | |
| K933050 | CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH | FOZ | Substantially Equivalent | |
| K915697 | CRITIKON VITAL SIGNS MODULE | DXN | Substantially Equivalent | |
| K921295 | INTRAVENOUS CATHETERS MODIFICATIONS | FGO | Substantially Equivalent | |
| K912188 | DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 | MHX | Substantially Equivalent | |
| K911769 | RATEMINDER(TM) V INFUSION PUMP, MODIFICATION | FRN | Substantially Equivalent | |
| K902092 | RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY | FRN | Substantially Equivalent | |
| K894100 | OXYTRAK(TM) PULSE OXIMETER | DQA | Substantially Equivalent | |
| K893546 | OPTICALLY CLEAR RADIOPAQUE CATHETER | FOZ | Substantially Equivalent | |
| K874546 | SIM MODULE | FRN | Substantially Equivalent | |
| K875174 | RATEMINDER V INFUSION PUMP | FRN | Substantially Equivalent | |
| K874442 | DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER | DQA | Substantially Equivalent | |
| K875177 | J&J SCALP VEIN INFUSION SETS | FOZ | Substantially Equivalent | |
| K874378 | DINAMAP VITAL SIGNS MONITOR, MODEL 8100T | DXN | Substantially Equivalent | |
| K873729 | RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K871418 | VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200) | DXN | Substantially Equivalent | |
| K861644 | CRITIKON 48-HOUR AIR ELIMINATING FILTER | FPB | Substantially Equivalent | |
| K854434 | DINAMAP VITAL SIGNS MONITOR MODEL 8100 | DXN | Substantially Equivalent | |
| K853701 | JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL | FOZ | Substantially Equivalent | |
| K844116 | CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC | DXG | Substantially Equivalent | |
| K844839 | DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX | DXN | Substantially Equivalent | |
| K850507 | CRITIKON I.V. ADMINISTRAION SET | FPA | Substantially Equivalent | |
| K843141 | CRITIKON HEPARIN-COATED CARDIOVASCULAR | LDF | Substantially Equivalent | |
| K842316 | CRITIKON TRIPLE-LUMEN CENTRAL VENOUS | DQY | Substantially Equivalent | |
| K842075 | CRITIKON I.V. FILTER | FPB | Substantially Equivalent | |
| K833939 | NITROGLYCERIN I.V. ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K833918 | INFUSION PORT BALLOON THERMODILUTION | DYG | Substantially Equivalent | |
| K833572 | HEPARIN-COATED BALLOON THERMODILUT | DYG | Substantially Equivalent | |
| K832916 | INIVOX ELECTRODE/CATHETER SYS | LLE | Substantially Equivalent | |
| K832656 | DINAMAP VITAL SIGNS MONITOR #1846P | DXN | Substantially Equivalent | |
| K831967 | CRITIKON CARDIAC OUTPUT COMPUTER | DXG | Substantially Equivalent | |
| K831761 | SIMPLICITY PLUS | FRN | Substantially Equivalent | |
| K831515 | DINAMAP VITAL SIGNS MONITOR #1846 | DXN | Substantially Equivalent | |
| K830972 | I.V. CATHETER PLACEMENT UNIT POLYURETH | FOZ | Substantially Equivalent | |
| K823433 | BALLOON THERMODILUTION CATHETER #7164& | DYG | Substantially Equivalent | |
| K821936 | CRITIKON OXYGEN MONITOR, MODEL 8030 | KLK | Substantially Equivalent | |
| K821890 | CRITIKON #817 ESOPHAGEAL MULTI-PROBE | BZT | Substantially Equivalent | |
| K813347 | CRITIKON TRANSCUTANEOUS GAS MONITORS | KLK | Substantially Equivalent | |
| K813527 | DINAMAP ADULT/PED./NEONATAL VITAL SIGNS | DXN | Substantially Equivalent | |
| K813345 | CRITIKON I.V. CATHETER PLACEMENT UNIT | FOZ | Substantially Equivalent | |
| K811107 | IV SETS | FPA | Substantially Equivalent | |
| K803078 | SIMPLICITY INFUSION PUMP MODEL 2100A | FRN | Substantially Equivalent | |
| K801546 | THE SIMPLICITY PUMP #2100 INFUSION PUMP | FRN | Substantially Equivalent | |
| K792105 | CRITIKON DUAL CHANNEL RECORDER | DSF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- DYGCatheter, Flow Directed
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- DQYCatheter, Percutaneous
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- FGODislodger, Stone, Flexible
- DPSElectrocardiograph
- LDFElectrode, Pacemaker, Temporary
- FPBFilter, Infusion Line
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- FRNPump, Infusion
- DSFRecorder, Paper Chart
- FPASet, Administration, Intravascular
- BZTStethoscope, Esophageal, With Electrical Conductors
- LLEStimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- MSXSystem, Network And Communication, Physiological Monitors
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain