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

Smiths Medical MD, Inc. · Predicate Candidate Screening

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

98 daysmedian FDA review time

218 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K112407	SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS	Smiths Medical MD, Inc.	2012-02-09	171	0
K111386	MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLB	Smiths Medical MD, Inc.	2011-08-29	103	12
K101180	GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPP	Smiths Medical MD, Inc.	2010-08-03	98	0
K091181	LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS	Smiths Medical MD, Inc.	2009-06-12	50	0
K082783	CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND PO	Smiths Medical MD, Inc.	2008-12-17	85	0
K081156	CADD MEDICATION CASSETTE RESERVOIR	Smiths Medical MD, Inc.	2008-07-18	86	10
K080743	LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP	Smiths Medical MD, Inc.	2008-04-25	39	0
K072144	CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICAT	Smiths Medical MD, Inc.	2008-03-07	218	7
K072955	CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21	Smiths Medical MD, Inc.	2008-02-13	117	0
K072657	POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C.	Smiths Medical MD, Inc.	2007-12-14	85	0
K072059	GRIPPER MICRO NEEDLE	Smiths Medical MD, Inc.	2007-11-01	98	0
K070116	POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENO	Smiths Medical MD, Inc.	2007-05-23	131	0
K062592	CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE	Smiths Medical MD, Inc.	2006-11-29	89	0
K062323	DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLU	Smiths Medical MD, Inc.	2006-11-01	84	5
K060036	PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANT	Smiths Medical MD, Inc.	2006-05-17	132	0
K051568	CADD-MS 3 AMBULATORY INFUSION PUMP	Smiths Medical MD, Inc.	2005-11-17	156	2
K042172	CLEO 90 INFUSION SET	Smiths Medical MD, Inc.	2004-10-07	57	0
K031738	SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE	Smiths Medical MD, Inc.	2004-05-27	358	3
K040636	CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE	Smiths Medical MD, Inc.	2004-05-19	70	5
K033686	PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM	Smiths Medical MD, Inc.	2004-01-23	60	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