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American Edwards Laboratories · Predicate Candidate Screening

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

47 daysmedian FDA review time

139 days90th percentile

89clearances measured

K-number	Device	Applicant	Decided	Review days
K873485	EDSLAB (R) OCCLUSION BALLOON CATHETER	American Edwards Laboratories	1987-12-03	94
K872596	TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30	American Edwards Laboratories	1987-09-30	90
K872529	THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2	American Edwards Laboratories	1987-09-15	81
K870444	HOMEPRO II VOLUMETRIC INFUSION PUMP	American Edwards Laboratories	1987-04-17	73
K864997	MEDTRAC VP VOLUMETRIC INFUSION PUMP	American Edwards Laboratories	1987-02-27	67
K864330	SHEAR FORCE GAUGE	American Edwards Laboratories	1987-01-06	63
K862724	VEIN VALVE CUTTER	American Edwards Laboratories	1987-01-02	169
K864155	MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS	American Edwards Laboratories	1986-11-20	28
K863596	CHIN-FOGARTY INFLATION DEVICE	American Edwards Laboratories	1986-11-20	66
K863986	XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES	American Edwards Laboratories	1986-10-31	17
K862872	FLEXIBLE VISUALIZATION CATHETER	American Edwards Laboratories	1986-10-24	86
K863605	ARTHROSCOPIC IRRIGATION PUMP	American Edwards Laboratories	1986-10-03	17
K863604	DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE	American Edwards Laboratories	1986-10-03	17
K863598	VIDEO CAMERA SYSTEM	American Edwards Laboratories	1986-10-02	17
K863696	ARTHROSCOPIC SURGICAL POWER DEVICE	American Edwards Laboratories	1986-09-29	7
K863597	AMERICAN EDWARDS 4.0 MM ARTHROSCOPE	American Edwards Laboratories	1986-09-25	10
K862547	MECHANICAL INFLATION DEVICE	American Edwards Laboratories	1986-09-03	62
K855000	RATEMINDER III INFUSION DEVICE	American Edwards Laboratories	1986-02-12	61
K853514	RIGID ENDOSCOPE	American Edwards Laboratories	1985-10-04	43
K853337	TROCAR/CANNULA/SHEATH SET	American Edwards Laboratories	1985-08-23	14
K852759	AMERICAN EDWARDS LABORATORIES FLEXISCOPE	American Edwards Laboratories	1985-08-22	55
K852324	URETERAL DILATOR	American Edwards Laboratories	1985-08-21	83
K852793	URETERAL DILATOR/SHEATH SET	American Edwards Laboratories	1985-08-09	39
K851374	AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE	American Edwards Laboratories	1985-06-28	81
K850954	URETERAL DILATOR & URETERAL STONE DISLODGER	American Edwards Laboratories	1985-04-03	26
K850790	DIAFLEX OCCLUSION BALLOON CATHETER	American Edwards Laboratories	1985-03-25	27
K841374	HOME PRO VOLUMETRIC INFUSION PUMP	American Edwards Laboratories	1985-02-15	318
K842105	RIGHT VENTRICULAR EJECTION FRACTION-	American Edwards Laboratories	1985-01-15	235
K845048	NEPHROSTOMY DRAINAGE CATHETER & STIFFENER	American Edwards Laboratories	1985-01-15	15
K845047	NEPHROSTOMY GUIDEWIRE SHEATH	American Edwards Laboratories	1985-01-15	15
K841401	SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER	American Edwards Laboratories	1985-01-14	286
K844090	PERCUTANEOUS NEPHROSTOMY TROCAR SYS	American Edwards Laboratories	1984-12-05	44
K842410	AMER. EDWARDS LAB FLEXISCOPE	American Edwards Laboratories	1984-11-05	139
K833763	PERICARDIAL PATCH	American Edwards Laboratories	1984-11-01	372
K843274	MODULAR VOLUMETRIC INFUSION PUMP SYS	American Edwards Laboratories	1984-10-19	60
K842481	AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE	American Edwards Laboratories	1984-10-18	115
K842632	DILATOR/SHEATH SET	American Edwards Laboratories	1984-10-02	88
K842639	AMER. EDWARDS LAB DIAFLEX URETERAL DILA	American Edwards Laboratories	1984-10-02	85
K842206	DIAFLEX NEPHROSTOMY BALLOON DILATOR	American Edwards Laboratories	1984-10-02	120
K841607	AMERICAN EDWARDS LABS FLEXISCOPE	American Edwards Laboratories	1984-08-18	121
K842323	AMER. EDWARDS LAB FLEXISCOPE OBTURATOR	American Edwards Laboratories	1984-08-17	65
K834429	PERIPHERAL DILATATION ANGIOPLASTY-CATH	American Edwards Laboratories	1984-08-10	239
K842799	PERCUTANEOUS ANGIOSCOPE DELIVERY CATH	American Edwards Laboratories	1984-08-10	24
K842798	INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH	American Edwards Laboratories	1984-08-10	24
K841922	ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232	American Edwards Laboratories	1984-07-13	64
K834547	ANGIOSCOPY CATHETER	American Edwards Laboratories	1984-06-11	167
K833997	CO-SET	American Edwards Laboratories	1984-04-17	148
K840746	URETERAL DILATOR	American Edwards Laboratories	1984-04-13	85
K834459	DIAGNOSTIC RADIOLOGY CATHETERS	American Edwards Laboratories	1984-02-04	47
K834220	HYBRID PERIPHERAL DILATION CATHETER	American Edwards Laboratories	1984-01-27	53

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