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

KPF — Predicate Candidate Screening

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

101 daysmedian FDA review time

226 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K061515	RENALSOFT	Baxter Healthcare Corp	2006-09-11	102	2
K990953	RENAL LINK	Baxter Healthcare Corp	1999-06-18	88	5
K970989	CYBERREN	Cybernius Medical , Ltd.	1997-07-24	128	0
K955762	PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PR	Fresenius USA, Inc.	1996-07-31	226	0
K913515	TOTAL CONTAINMENT DEVICE	Denco	1994-05-26	1023	0
K875121	AMICON EQUALINE FLUID BALANCE SYSTEM	Amicon, Inc.	1988-02-19	66	0
K874020	ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE	Abbott Laboratories	1988-01-29	119	0
K821328	C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP	Medionics International , Ltd.	1982-07-28	85	0
K802831	GAMBRO PERITONEAL DIALYSIS MONITOR	Gambro, Inc.	1980-12-18	36	0
K800496	CYCLER W/5 OR 10 HR. FILL/DWELL TIMER	American Medical Products, Inc.	1980-07-21	139	0
K791676	PERITONEAL DIALYSIS CYCLER MODEL PDC1000	J.M. Sounds Electronics Co.	1979-12-06	101	0
K791584	CYLER/HEATER FOR PERITONEAL DIALYSIS	American Medical Products, Inc.	1979-11-16	91	0
K790091	AMP AUTOMATIC CYCLER STAND	American Medical Products, Inc.	1979-02-16	31	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