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

CET — Predicate Candidate Screening

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

81 daysmedian FDA review time

121 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K970124	LIPASE REAGENT SET (COLIPASE METHOD)	Teco Diagnostics	1997-03-06	51
K940457	LIPASE REAGENT SYSTEM	Medical Diagnostic Technologies, Inc.	1994-06-02	121
K915706	LIPASE REAGENT SET	Tech Intl. Co.	1992-02-18	81
K901858	MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST	E.I. Dupont DE Nemours & Co., Inc.	1990-06-12	49
K893718	DELTATEST (R) LIPASE II	Electro-Nucleonics, Inc.	1989-09-28	134
K885078	LIPASE SR LIQUID STABLE REAGENT SET	Medical Analysis Systems, Inc.	1989-03-13	95
K864438	BECKMAN EPSILON(TM) LIPASE TEST KIT	Beckman Instruments, Inc.	1987-03-12	120
K862440	PARAMAX LIPASE REAGENT	American Dade	1986-08-04	39
K844240	ENZYGNOST LIPASE TEST	Behring Diagnostics, Inc.	1985-02-12	103
K823860	NUCLIPASE (I125) PANCREATIC LIPASE	Nuclear Diagnostics, Inc.	1983-04-18	117
K812794	LIPASE	Pointe Scientific, Inc.,	1981-10-20	14
K792289	LIPASE TEST KIT	Mallinckrodt Critical Care	1979-12-18	35
K791922	HARLECO BRAND CLINICARD LIPASE TEST SET	Dade, Baxter Travenol Diagnostics, Inc.	1979-11-27	62
K790796	LIPASE REAGENT SET	Alta Diagnostics, Inc.	1979-07-17	84
K770364	ACA LIPASE ANALYTICAL TEST PACK	E.I. Dupont DE Nemours & Co., Inc.	1977-04-15	51

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