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

Medisystems Corp. — Predicate Candidate Screening

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

90 daysmedian FDA review time

302 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K062953	MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREME	Medisystems Corp.	2007-02-12	136	0
K010279	MEDISYSTEMS LUER ACCESS INJECTION SITE	Medisystems Corp.	2001-05-29	119	0
K002372	ACCESS ALERT GAUGE	Medisystems Corp.	2000-10-25	82	0
K994306	REVERSO	Medisystems Corp.	2000-03-20	90	0
K990803	MEDISYSTEMS BUTTONHOLE NEEDLE SETS	Medisystems Corp.	2000-01-06	302	1
K983076	MEDISYSTEMS TRANSDUCER PROTECTOR	Medisystems Corp.	1998-11-25	84	0
K971860	MEDISYSTEMS DIALYSIS PRIMING SETS	Medisystems Corp.	1997-08-18	90	0
K963668	MEDISYSTEMS PERITONEAL DIALYSIS SETS	Medisystems Corp.	1997-08-15	336	0
K970536	MEDISYSTEMS TRANDUCER PROTECTOR	Medisystems Corp.	1997-05-12	89	0
K953823	ARTERIAL VENOUS BLOOD TUBING SET	Medisystems Corp.	1996-09-23	405	0
K932074	MEDISYSTEMS APHERESIS NEEDLE WITH GUARD	Medisystems Corp.	1994-02-18	296	0
K910734	MEDISYSTEMS HEMODIALYSIS FISTULA SET	Medisystems Corp.	1991-06-20	119	2
K910733	MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE	Medisystems Corp.	1991-06-06	105	0
K895856	MEDISYSTEMS TRANSDUCER PROTECTOR	Medisystems Corp.	1989-11-24	53	0
K862002	MEDISYSTEMS PHERESIS NEEDLE	Medisystems Corp.	1986-06-27	35	0
K823068	MEDISYSTEMS FISTULA NEEDLES	Medisystems Corp.	1983-01-26	99	0
K823069	KF-E SERIES HOLLOW FIBER DIALYZER	Medisystems Corp.	1983-01-21	94	0
K812910	MEDISYSTEMS NEEDLES & SYRINGES	Medisystems Corp.	1981-11-06	18	0
K812353	KF-E SERIES OF HOLLOW FIBER DIALYZERS	Medisystems Corp.	1981-09-16	28	0
K811838	MEDISYSTEMS FISTULA NEEDLE	Medisystems Corp.	1981-09-08	69	0
K811839	MEDISYSTEM NEGATIVE PRESSURE	Medisystems Corp.	1981-09-08	69	0
K811837	I.V. ADMINISTRATION SET	Medisystems Corp.	1981-07-10	9	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