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

KRB — Predicate Candidate Screening

37 FDA 510(k) clearances under this product code; the 50 most recent screened below.

61 daysmedian FDA review time

257 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K171620	PiCCO Catheter	Pulsion Medical Systems SE	2018-02-21	264	0
K100739	VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R	Edwards Lifesciences, LLC	2010-12-07	266	0
K072364	PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES	Pulsion Medical Systems AG	2007-09-19	28	0
K020587	PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TE	Pulsion Medical Systems AG	2002-05-23	90	0
K991886	PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-	Pulsion Medical Systems, Inc.	2000-05-11	344	1
K936182	CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT	Ohmeda Medical	1994-03-25	88	0
K915627	PACEVIEW	Micromedical Industries, Ltd.	1992-03-27	109	0
K912172	SAFEWEDGE(TM) RELIEF VALVE DEVICE	Sunscope Intl., Inc.	1991-09-27	134	0
K902627	INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.	Biometric Research Institute, Inc.	1991-02-25	257	0
K900710	INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER	Intec Medical, Inc.	1990-10-19	247	0
K900317	PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER	Elecath	1990-06-22	150	0
K892941	CCO SYSTEM MODEL SP1467,SP5567,SP6267	Spectramed, Inc.	1989-11-06	199	0
K884318	THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM	Abbott Laboratories	1988-12-13	61	0
K881893	NUMED BALLOON THERMODILUTION CATHETER	NuMED, Inc.	1988-09-06	124	0
K874522	MODIFIED MYOCARDIAL TEMPERATURE SENSOR	Mon-A-Therm, Inc.	1988-01-29	88	0
K864818	ACKRAD TDI SET	Ackrad Laboratories	1987-04-09	121	0
K843410	FLOW-DIRECTED PEDIATRIC THERMODIL- CATH	Andover Medical, Inc.	1984-11-20	81	0
K843412	FLOW DIRECTED THERMODILUTION CATH W/VEN	Andover Medical, Inc.	1984-11-20	81	0
K840992	THERMODILUTION CATHETER	Gould, Inc.	1984-05-23	77	0
K840824	HEPARIN COATED THERMODILUTION CATHETERS	Gould, Inc.	1984-05-23	89	0
K830909	MIKRO-TIP CATH. PRESSURE TRANSDUCER	Millar Instruments, Inc.	1983-04-18	28	0
K823435	MON-A-THERM MYOCARDIAL TEMP. SENSOR	Burditt & Calkins-Siemens-Elema	1982-12-30	44	0
K812800	FLOW-DIRECTED THERMODILUTION CATHETER	Sorensen Research	1981-10-20	14	1
K811537	MODEL SP 5507 5-LUMEN THERMODILUTION CAT	Gould, Inc.	1981-06-18	17	0
K811411	SWAN-GANZ HEPARIN COATED, ETC. CATHETER	American Edwards Laboratories	1981-06-12	24	0
K811399	EDSLAB CLOSED INJECTATE DELIVERY SYSTEM	American Edwards Laboratories	1981-06-09	21	0
K811480	THERMODILUTION KIT	American Pharmaseal Div. Ahsc	1981-06-09	13	0
K810730	MODEL SP5107 THERMODILUTION CATHETER	Gould, Inc.	1981-03-27	10	0
K802133	BENTLEY THEROMODILUTION CATHETER #BTD-7F	Bentley Laboratories, Inc.	1980-09-26	22	0
K801552	MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR	Edwards Laboratories	1980-07-28	20	0
K800836	KMA FLOW DIRECTED THERMODILUTION CATHETE	Kma, Inc.	1980-04-24	9	0
K791873	USCI SAFE-T-CLOTH THERMODILUTION CAT.	C.R. Bard, Inc.	1979-11-13	53	0
K791026	4F STERILE BALLOON-LESS, CATHETER 913-28	Waters Assoc., Inc.	1979-06-22	18	0
K771663	PROBE & CATHETER	Edwards Laboratories	1977-09-20	21	0
K760067	CATHETER, THERMAL DILUTION, OPEN CHEST	Instrumentation Laboratory CO	1976-07-21	35	0
K760065	CATHETER, THERMAL DILUTION, PEDIATRIC	Instrumentation Laboratory CO	1976-07-21	35	0
K760064	CATHETER, THERMAL DILUTION, ANIMAL & PED	Instrumentation Laboratory CO	1976-07-21	35	0

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