Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Nipro Medical Corporation · Predicate Candidate Screening

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

183 daysmedian FDA review time

331 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K261399	ELISIO™-HX	Nipro Medical Corporation	2026-07-28	90	0
K253047	PRESSONE™	Nipro Medical Corporation	2026-03-24	183	0
K260533	ELISIO™-H	Nipro Medical Corporation	2026-03-19	30	0
K222852	Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle	Nipro Medical Corporation	2023-05-25	246	0
K212677	aboNT SYRINGE	Nipro Medical Corporation	2022-04-15	234	0
K190037	Cronus HP PTA Balloon Catheter	Nipro Medical Corporation	2019-10-24	289	0
K191359	Nipro Syringe	Nipro Medical Corporation	2019-10-09	141	0
K182940	Surdial DX Hemodialysis System	Nipro Medical Corporation	2019-07-19	269	1
K173029	Nipro Syringe	Nipro Medical Corporation	2018-03-30	183	0
K161681	Nipro SafeTouch IV Catheter	Nipro Medical Corporation	2017-03-08	264	0
K160444	FB-U Hemodialyzer	Nipro Medical Corporation	2017-02-08	357	0
K151141	Cronus HP - High Pressure Peripheral Balloon Catheter	Nipro Medical Corporation	2016-01-14	260	0
K140191	ELISIO-H HEMODIALYZER	Nipro Medical Corporation	2014-04-14	77	0
K140136	NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE	Nipro Medical Corporation	2014-02-14	28	0
K131935	ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER	Nipro Medical Corporation	2013-12-20	176	0
K131381	ELISIO-H HEMODIALYZER	Nipro Medical Corporation	2013-12-19	219	0
K132153	SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER	Nipro Medical Corporation	2013-12-05	146	0
K122952	NIPRO PUREFLUX-L HEMODIALYZER	Nipro Medical Corporation	2013-12-04	435	0
K131641	MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETE	Nipro Medical Corporation	2013-08-28	85	1
K122343	PUREFLUX-H HEMODIALYZER	Nipro Medical Corporation	2013-05-07	277	0
K122347	ELISIO-H AND ELISIO-M HEMODIALYZERS	Nipro Medical Corporation	2013-05-01	271	0
K130049	MONOJECT 12ML SYRINGE	Nipro Medical Corporation	2013-02-14	37	0
K120490	QUICK SAMPLER HOLDER	Nipro Medical Corporation	2012-12-27	314	0
K113469	NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE	Nipro Medical Corporation	2012-10-18	331	0
K113471	NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET	Nipro Medical Corporation	2012-10-18	331	0
K113470	NIPRO SAFE TOUCH HUBER INFUSION SET	Nipro Medical Corporation	2012-10-17	330	0
K112628	NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING	Nipro Medical Corporation	2012-09-28	385	1
K113429	SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER	Nipro Medical Corporation	2012-03-12	112	0
K100520	NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER	Nipro Medical Corporation	2010-03-17	22	0
K092246	NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M28550	Nipro Medical Corporation	2009-11-12	107	0
K091279	NIPRO DISPOSABLE SYRINGE	Nipro Medical Corporation	2009-08-12	103	0
K072988	NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1	Nipro Medical Corporation	2008-02-21	121	0
K071145	NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE	Nipro Medical Corporation	2007-09-07	136	1
K060034	NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC US	Nipro Medical Corporation	2006-02-28	54	0
K051828	NIPRO SUREFUSER AMBULATORY INFUSION PUMP	Nipro Medical Corporation	2005-12-15	162	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