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

Waters Assoc., Inc. — Predicate Candidate Screening

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

34 daysmedian FDA review time

58 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K811975	MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL	Waters Assoc., Inc.	1981-07-27	14
K802481	7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH	Waters Assoc., Inc.	1980-10-31	24
K801852	MRM-2 OXYGEN CONSUMPTION MONITOR	Waters Assoc., Inc.	1980-08-20	16
K801431	PAN-AM MYELOGRAM TRAY	Waters Assoc., Inc.	1980-08-12	55
K791661	SYSTEM CONTROLLER 720 SERIES	Waters Assoc., Inc.	1979-09-24	34
K791026	4F STERILE BALLOON-LESS, CATHETER 913-28	Waters Assoc., Inc.	1979-06-22	18
K782175	CARTRIDGE HOLDER, RCM 100	Waters Assoc., Inc.	1979-02-15	49
K790145	SOLVENT DELIVERY SYSTEM	Waters Assoc., Inc.	1979-02-15	28
K781805	CARDIAC COMPUTERS, CO-10 & CO-10R	Waters Assoc., Inc.	1979-01-29	97
K781915	DATA MODULE	Waters Assoc., Inc.	1979-01-10	57
K781692	CALIBRATOR, DYNAMIC	Waters Assoc., Inc.	1978-11-29	56
K781264	PAB CONVENIENCE TRAY	Waters Assoc., Inc.	1978-09-20	58
K780245	RECORDER, RE-100P HOT STYLUS STRIP CHART	Waters Assoc., Inc.	1978-03-27	42
K780031	FLUORESCENCE DETECTOR MODEL 420	Waters Assoc., Inc.	1978-01-20	11
K772311	WISP MODEL 710	Waters Assoc., Inc.	1978-01-12	24
K761166	TC-1 CARDIAC OUTPUT COMPUTER	Waters Assoc., Inc.	1976-12-09	8

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