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

Chf Solutions, Inc. — Predicate Candidate Screening

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

76 daysmedian FDA review time

244 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K192756	Aquadex FlexFlow System 2.0	Chf Solutions, Inc.	2020-02-24	147	1
K071854	AQUADEX FLEXFLOW SYSTEM	Chf Solutions, Inc.	2007-09-07	64	0
K070512	MODIFICATION TO AQUADEX FLEXFLOW SYSTEM	Chf Solutions, Inc.	2007-04-27	64	0
K062922	MODIFICATION TO AQUADEX FLEXFLOW SYSTEM	Chf Solutions, Inc.	2006-12-13	76	0
K060008	AQUADEX FLEXFLOW SYSTEM	Chf Solutions, Inc.	2006-02-02	30	0
K050609	AQUADEX SYSTEM	Chf Solutions, Inc.	2005-11-09	244	0
K041791	5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)	Chf Solutions, Inc.	2004-09-10	70	0
K040489	AQUADEX SYSTEM 100, MODEL A1100	Chf Solutions, Inc.	2004-04-27	61	0
K031689	DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)	Chf Solutions, Inc.	2003-12-23	204	0
K023874	SYSTEM 100 ULTRAFILTRATION CATHETER	Chf Solutions, Inc.	2003-11-20	364	0
K024124	SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS POR	Chf Solutions, Inc.	2003-03-14	88	0
K023224	INFUSION CATHETER EXTENSION SET	Chf Solutions, Inc.	2002-10-25	28	0
K013733	SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILT	Chf Solutions, Inc.	2002-06-03	206	0

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