Atlas FDA

KRB

37 FDA 510(k) clearances · Product code

61 daysmedian time to decision
257 days90th percentile
37clearances measured

FDA profile

Official device name
Probe, Thermodilution
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1915
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2020: 16 · 2021: 22 · 2022: 21 · 2024: 40 · 2025: 24 · 2026: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PiCCO Catheter (K171620)Pulsion Medical Systems SE2018-02-21
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 (K100739)Edwards Lifesciences, LLC2010-12-07
PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES (K072364)Pulsion Medical Systems AG2007-09-19
PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 (K020587)Pulsion Medical Systems AG2002-05-23
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR (K991886)Pulsion Medical Systems, Inc.2000-05-11
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT (K936182)Ohmeda Medical1994-03-25
PACEVIEW (K915627)Micromedical Industries, Ltd.1992-03-27
SAFEWEDGE(TM) RELIEF VALVE DEVICE (K912172)Sunscope Intl., Inc.1991-09-27
INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. (K902627)Biometric Research Institute, Inc.1991-02-25
INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER (K900710)Intec Medical, Inc.1990-10-19
PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER (K900317)Elecath1990-06-22
CCO SYSTEM MODEL SP1467,SP5567,SP6267 (K892941)Spectramed, Inc.1989-11-06
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM (K884318)Abbott Laboratories1988-12-13
NUMED BALLOON THERMODILUTION CATHETER (K881893)NuMED, Inc.1988-09-06
MODIFIED MYOCARDIAL TEMPERATURE SENSOR (K874522)Mon-A-Therm, Inc.1988-01-29
ACKRAD TDI SET (K864818)Ackrad Laboratories1987-04-09
FLOW-DIRECTED PEDIATRIC THERMODIL- CATH (K843410)Andover Medical, Inc.1984-11-20
FLOW DIRECTED THERMODILUTION CATH W/VEN (K843412)Andover Medical, Inc.1984-11-20
THERMODILUTION CATHETER (K840992)Gould, Inc.1984-05-23
HEPARIN COATED THERMODILUTION CATHETERS (K840824)Gould, Inc.1984-05-23
MIKRO-TIP CATH. PRESSURE TRANSDUCER (K830909)Millar Instruments, Inc.1983-04-18
MON-A-THERM MYOCARDIAL TEMP. SENSOR (K823435)Burditt & Calkins-Siemens-Elema1982-12-30
FLOW-DIRECTED THERMODILUTION CATHETER (K812800)Sorensen Research1981-10-20
MODEL SP 5507 5-LUMEN THERMODILUTION CAT (K811537)Gould, Inc.1981-06-18
SWAN-GANZ HEPARIN COATED, ETC. CATHETER (K811411)American Edwards Laboratories1981-06-12
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM (K811399)American Edwards Laboratories1981-06-09
THERMODILUTION KIT (K811480)American Pharmaseal Div. Ahsc1981-06-09
MODEL SP5107 THERMODILUTION CATHETER (K810730)Gould, Inc.1981-03-27
BENTLEY THEROMODILUTION CATHETER #BTD-7F (K802133)Bentley Laboratories, Inc.1980-09-26
MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR (K801552)Edwards Laboratories1980-07-28
KMA FLOW DIRECTED THERMODILUTION CATHETE (K800836)Kma, Inc.1980-04-24
USCI SAFE-T-CLOTH THERMODILUTION CAT. (K791873)C.R. Bard, Inc.1979-11-13
4F STERILE BALLOON-LESS, CATHETER 913-28 (K791026)Waters Assoc., Inc.1979-06-22
PROBE & CATHETER (K771663)Edwards Laboratories1977-09-20
CATHETER, THERMAL DILUTION, OPEN CHEST (K760067)Instrumentation Laboratory CO1976-07-21
CATHETER, THERMAL DILUTION, PEDIATRIC (K760065)Instrumentation Laboratory CO1976-07-21
CATHETER, THERMAL DILUTION, ANIMAL & PED (K760064)Instrumentation Laboratory CO1976-07-21

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Every clearance here is in the API, with alerts when new ones post.