Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

DJY — Predicate Candidate Screening

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

43 daysmedian FDA review time

132 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K890113	THE CDI(R) SYSTEM 400	Cardiovascular Devices, Inc.	1989-05-23	132
K883615	LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73	Supelco, Inc.	1988-12-16	114
K881361	SOLID PHASE EXTRACTION TUBES	Supelco, Inc.	1988-08-08	174
K850963	DUPONT PREP TYPE SI EXTRACITON CARTRIDGE	E.I. Dupont DE Nemours & Co., Inc.	1985-03-25	17
K840985	TRISACRYL GF 05 & TRISACRYL GF 2000	Lkb Instruments, Inc.	1984-04-19	43
K832198	HC40/HC75 PREPACKED COLUMS	Hamilton Co.	1983-08-12	36
K831289	PREFILLED IEC COLUMNS	Berwick Medical Products, Inc.	1983-06-16	57
K830693	DUPONT PREP TYPE AS EXTRACTION CARTRIDE	E.I. Dupont DE Nemours & Co., Inc.	1983-04-05	29
K830692	DUPONT PREP OD EXTRACTION CARTRIDE	E.I. Dupont DE Nemours & Co., Inc.	1983-04-05	29
K823697	PREP TYPE A EXTRACTION CARTRIDGE	E.I. Dupont DE Nemours & Co., Inc.	1983-01-05	27
K800061	BOND ELUT COLUMNS	Analytichem International, Inc.	1980-03-12	63

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