Product Code: KRB FDA class 2 21 CFR 870.1915

Probe, Thermodilution

Cardiovascular

This device is a thermodilution probe used in conjunction with a pulmonary artery catheter to measure cardiac output by detecting temperature changes in blood following injection of a cold bolus, providing hemodynamic data critical to intensive care management. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRB, regulated under 21 CFR 870.1915 within the Cardiovascular specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: KRB
Device Class: FDA class 2
Regulation Number: 870.1915
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K171620	PiCCO Catheter	Feb 21, 2018	Substantially Equivalent	Pulsion Medical Systems SE
K100739	VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5	Dec 07, 2010	Substantially Equivalent	Edwards Lifesciences, LLC
K072364	PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES	Sep 19, 2007	Substantially Equivalent	Pulsion Medical Systems AG
K020587	PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046	May 23, 2002	Substantially Equivalent	Pulsion Medical Systems AG
K991886	PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR	May 11, 2000	Substantially Equivalent	Pulsion Medical Systems, Inc.
K936182	CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT	Mar 25, 1994	Substantially Equivalent	Ohmeda Medical
K915627	PACEVIEW	Mar 27, 1992	Substantially Equivalent	Micromedical Industries, Ltd.
K912172	SAFEWEDGE(TM) RELIEF VALVE DEVICE	Sep 27, 1991	Substantially Equivalent	Sunscope Intl., Inc.
K902627	INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.	Feb 25, 1991	Substantially Equivalent	Biometric Research Institute, Inc.
K900710	INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER	Oct 19, 1990	Substantially Equivalent	Intec Medical, Inc.
K900317	PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER	Jun 22, 1990	Substantially Equivalent	Elecath
K892941	CCO SYSTEM MODEL SP1467,SP5567,SP6267	Nov 06, 1989	Substantially Equivalent	Spectramed, Inc.
K884318	THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM	Dec 13, 1988	Substantially Equivalent	Abbott Laboratories
K881893	NUMED BALLOON THERMODILUTION CATHETER	Sep 06, 1988	Substantially Equivalent	NuMED, Inc.
K874522	MODIFIED MYOCARDIAL TEMPERATURE SENSOR	Jan 29, 1988	Substantially Equivalent	Mon-A-Therm, Inc.
K864818	ACKRAD TDI SET	Apr 09, 1987	Substantially Equivalent	Ackrad Laboratories
K843412	FLOW DIRECTED THERMODILUTION CATH W/VEN	Nov 20, 1984	Substantially Equivalent	Andover Medical, Inc.
K843410	FLOW-DIRECTED PEDIATRIC THERMODIL- CATH	Nov 20, 1984	Substantially Equivalent	Andover Medical, Inc.
K840992	THERMODILUTION CATHETER	May 23, 1984	Substantially Equivalent	Gould, Inc.
K840824	HEPARIN COATED THERMODILUTION CATHETERS	May 23, 1984	Substantially Equivalent	Gould, Inc.
K830909	MIKRO-TIP CATH. PRESSURE TRANSDUCER	Apr 18, 1983	Substantially Equivalent	Millar Instruments, Inc.
K823435	MON-A-THERM MYOCARDIAL TEMP. SENSOR	Dec 30, 1982	Substantially Equivalent	Burditt & Calkins-Siemens-Elema
K812800	FLOW-DIRECTED THERMODILUTION CATHETER	Oct 20, 1981	Substantially Equivalent	Sorensen Research
K811537	MODEL SP 5507 5-LUMEN THERMODILUTION CAT	Jun 18, 1981	Substantially Equivalent	Gould, Inc.
K811411	SWAN-GANZ HEPARIN COATED, ETC. CATHETER	Jun 12, 1981	Substantially Equivalent	American Edwards Laboratories
K811480	THERMODILUTION KIT	Jun 09, 1981	Substantially Equivalent	American Pharmaseal Div. Ahsc
K811399	EDSLAB CLOSED INJECTATE DELIVERY SYSTEM	Jun 09, 1981	Substantially Equivalent	American Edwards Laboratories
K810730	MODEL SP5107 THERMODILUTION CATHETER	Mar 27, 1981	Substantially Equivalent	Gould, Inc.
K802133	BENTLEY THEROMODILUTION CATHETER #BTD-7F	Sep 26, 1980	Substantially Equivalent	Bentley Laboratories, Inc.
K801552	MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR	Jul 28, 1980	Substantially Equivalent	Edwards Laboratories
K800836	KMA FLOW DIRECTED THERMODILUTION CATHETE	Apr 24, 1980	Substantially Equivalent	Kma, Inc.
K791873	USCI SAFE-T-CLOTH THERMODILUTION CAT.	Nov 13, 1979	Substantially Equivalent	C.R. Bard, Inc.
K791026	4F STERILE BALLOON-LESS, CATHETER 913-28	Jun 22, 1979	Substantially Equivalent	Waters Assoc., Inc.
K771663	PROBE & CATHETER	Sep 20, 1977	Substantially Equivalent	Edwards Laboratories
K760067	CATHETER, THERMAL DILUTION, OPEN CHEST	Jul 21, 1976	Substantially Equivalent	Instrumentation Laboratory CO
K760065	CATHETER, THERMAL DILUTION, PEDIATRIC	Jul 21, 1976	Substantially Equivalent	Instrumentation Laboratory CO
K760064	CATHETER, THERMAL DILUTION, ANIMAL & PED	Jul 21, 1976	Substantially Equivalent	Instrumentation Laboratory CO