Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

I-Flow Corp. — Predicate Candidate Screening

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

71 daysmedian FDA review time

283 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K063530	ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP,	I-Flow Corp.	2007-01-26	65	3
K063234	ON-Q INTRODUCERS	I-Flow Corp.	2006-11-21	27	0
K051401	ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I	I-Flow Corp.	2005-11-30	183	0
K052117	I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP	I-Flow Corp.	2005-09-09	36	3
K043456	MODIFICATION TO SOAKER CATHETER	I-Flow Corp.	2005-01-11	27	0
K040337	I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)	I-Flow Corp.	2004-05-24	103	0
K023883	HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYP	I-Flow Corp.	2002-12-20	29	0
K023827	PARAGON INFUSION SYSTEM WITH BOLUS	I-Flow Corp.	2002-12-13	25	0
K023318	I-FLOW ELASTOMERIC PUMP WITH BOLUS	I-Flow Corp.	2002-10-18	14	1
K022869	SOAKER CATHETER	I-Flow Corp.	2002-09-20	22	0
K020862	I-FLOW ELASTOMERIC PUMP	I-Flow Corp.	2002-03-26	8	1
K020660	HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYP	I-Flow Corp.	2002-03-20	19	0
K020251	PARAGON INFUSION SYSTEM	I-Flow Corp.	2002-02-15	22	0
K994374	SOAKER CATHETER	I-Flow Corp.	2000-03-03	67	0
K991543	INTRAOP CATHETER	I-Flow Corp.	1999-10-25	175	0
K992072	BOLUS ACCESSORY SET	I-Flow Corp.	1999-09-15	88	0
K991513	HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO	I-Flow Corp.	1999-06-21	52	1
K990425	SIDEKICK INFUSION KIT	I-Flow Corp.	1999-04-23	71	0
K984502	NERVE BLOCK INFUSION KIT	I-Flow Corp.	1999-03-04	76	0
K984441	KVO CHECK VALVE ACCESSORY, MODEL EV-0001	I-Flow Corp.	1999-02-22	70	0
K984063	PARAGON BASAL/BOLUS ADMINISTRATION SET	I-Flow Corp.	1999-02-09	85	0
K984146	PARAGON INFUSION	I-Flow Corp.	1999-02-09	82	0
K984638	PARAGON BOLUS ACCESSORY SET	I-Flow Corp.	1999-02-09	40	0
K982946	PAINBUSTER INFUSION KIT	I-Flow Corp.	1998-11-18	89	0
K980558	PAINBUSTER INFUSION SYSTEM	I-Flow Corp.	1998-05-28	104	0
K972173	MEDI-SIS SYRINGE INFUSION SYSTEM	I-Flow Corp.	1997-08-15	67	0
K955727	BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET	I-Flow Corp.	1996-02-08	52	0
K954059	TITAN 20 CC DRIVER	I-Flow Corp.	1995-09-29	31	0
K953028	TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET	I-Flow Corp.	1995-09-28	91	0
K952760	FIXED FLOW RATE GRAVITY ADMINISTRATION SETS	I-Flow Corp.	1995-08-18	63	0
K941418	INFUSION PUMP	I-Flow Corp.	1995-07-18	482	0
K940657	IV BAG PUMP	I-Flow Corp.	1995-02-03	353	0
K935811	BOLUS DISPENSER	I-Flow Corp.	1995-01-20	414	0
K924527	VIVUS 5000 INFUSION SYSTEM	I-Flow Corp.	1994-03-29	567	0
K923875	SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS	I-Flow Corp.	1993-05-13	283	1
K915646	VIVUS 50 AND VIVUS 100 PERSONAL INFUSER	I-Flow Corp.	1992-06-15	180	0
K913907	VIVUS PS (PROGRAMMING SOFTWARE)	I-Flow Corp.	1991-12-13	105	0
K904048	MULTI DRUG INFUSION SYSTEM	I-Flow Corp.	1990-10-01	27	0
K901978	MULTI-DRUG INFUSION SYSTEM	I-Flow Corp.	1990-09-28	149	0
K892210	MULTI-DRUG(TM) INFUSION SYSTEM	I-Flow Corp.	1989-08-28	147	0
K883003	MULTI-DRUG INFUSION SYSTEM	I-Flow Corp.	1988-10-14	88	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