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

JJH — Predicate Candidate Screening

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

77 daysmedian FDA review time

257 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K113731	ESENSOR RESPIRATORY VIRAL PANEL	Clinical Micro Sensors, Inc.	2012-09-10	266
K960298	VIVASPIN 4 10,000 MW	Vivascience, Inc.	1996-03-19	57
K943965	VIVAPORE 10	Vivascience, Inc.	1995-04-11	257
K943966	VIVAPORE 2	Vivascience, Inc.	1995-04-11	257
K941326	ULTRAFREE-CL	Millipore Corp.	1994-05-27	70
K935496	NANOSEP N10	Intersep , Ltd.	1994-04-26	162
K930168	CENTRICON -50 CONCENTRATOR	Amicon, Inc.	1993-08-05	204
K893733	CENTRICON CONCENTRATOR	Amicon, Inc.	1989-07-20	64
K871290	CENTRICELL(TM)	Polysciences, Inc.	1987-08-05	127
K870690	CENTRIPREP CONCENTRATOR	Amicon, Inc.	1987-03-19	28
K851393	DUPONT PREP FOUR-SOLVENT RETROFIT KIT	E.I. Dupont DE Nemours & Co., Inc.	1985-07-12	94
K833919	CENTRICON MICRO-CONCENTRATOR	Amicon, Inc.	1984-01-30	77
K801772	MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG	Radiation Technology, Inc.	1980-08-20	23
K770398	MINICON	Amicon, Inc.	1977-04-06	35
K760592	MINICON CONCENTRATOR	Amicon, Inc.	1976-11-23	77

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