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

Nipro Medical Corp. — Predicate Candidate Screening

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

77 daysmedian FDA review time

209 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K093985	NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE	Nipro Medical Corp.	2010-01-22	29	0
K081210	NIPRO SAFETOUCH HUBER INFUSTION SET	Nipro Medical Corp.	2008-10-21	175	1
K072024	NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING	Nipro Medical Corp.	2007-10-04	72	0
K063368	NIPRO BIOHOLE NEEDLE	Nipro Medical Corp.	2007-02-05	90	0
K063721	NIPRO SAFETOUCH II GAMMA	Nipro Medical Corp.	2007-01-12	28	0
K052474	NIPRO HYPODERMIC NEEDLE	Nipro Medical Corp.	2005-11-10	62	0
K051574	NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE	Nipro Medical Corp.	2005-08-26	73	0
K041779	NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L	Nipro Medical Corp.	2004-09-21	82	0
K032777	MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE	Nipro Medical Corp.	2003-11-14	67	0
K030683	NIPRO DISPOSABLE SYRINGES	Nipro Medical Corp.	2003-10-31	240	0
K022756	NIPRO BIO-FLEX CATHETER	Nipro Medical Corp.	2002-10-18	59	0
K013293	NIPRO HYPODERMIC NEEDLE	Nipro Medical Corp.	2001-12-14	73	0
K013287	NIPRO SAFELET CATH	Nipro Medical Corp.	2001-12-03	62	0
K011297	NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET	Nipro Medical Corp.	2001-06-20	51	1
K010264	NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROT	Nipro Medical Corp.	2001-04-27	88	0
K003394	APPALEAD GW+03XXXXXXR SERIES	Nipro Medical Corp.	2001-01-30	90	0
K001465	NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROT	Nipro Medical Corp.	2000-12-05	209	0
K002813	NIPRO SAFETOUCH SAFETY FISTULA NEEDLE	Nipro Medical Corp.	2000-11-21	74	1
K001251	SNIPER, MODEL OR-3872XX SERIES	Nipro Medical Corp.	2000-07-07	79	5
K992699	NIPRO BLOOD COLLECTION NEEDLE	Nipro Medical Corp.	2000-02-14	186	0
K000144	NIPRO INSULIN SYRINGE	Nipro Medical Corp.	2000-02-11	24	0
K992729	NIPRO LUER ADAPTOR	Nipro Medical Corp.	2000-01-13	153	0
K991623	NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA AR	Nipro Medical Corp.	1999-08-09	90	0
K971582	NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET	Nipro Medical Corp.	1997-12-22	236	0
K972206	NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR	Nipro Medical Corp.	1997-11-26	168	0
K972493	NIPRO DISPOSABLE SOLUTION INFUSION SET	Nipro Medical Corp.	1997-09-18	77	0
K970076	NIPRO DISPOSABLE SOLUTION INFUSION SET	Nipro Medical Corp.	1997-03-27	77	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