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

Smiths Medical Asd, Inc. — Predicate Candidate Screening

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

113 daysmedian FDA review time

312 days90th percentile

52clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232943	Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Spa	Smiths Medical Asd, Inc.	2024-05-31	254	0
K210833	Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionai	Smiths Medical Asd, Inc.	2021-11-26	252	0
K211634	Hypodermic Needle-Pro EDGE Safety Device	Smiths Medical Asd, Inc.	2021-08-26	91	0
K192375	Intellifuse Administration and Intellifuse Blood Administrat	Smiths Medical Asd, Inc.	2020-09-18	385	0
K181699	Level 1 Convective Warmer	Smiths Medical Asd, Inc.	2018-07-26	29	0
K172800	Portex® Lancet Point Spinal Needles with NRFit™ connectors,	Smiths Medical Asd, Inc.	2018-06-14	269	0
K172823	Portex NRFit Epidural Needles	Smiths Medical Asd, Inc.	2018-06-12	267	0
K172410	Portex NRFit Epidural Needles, Portex NRFit Spinal Needles,	Smiths Medical Asd, Inc.	2018-06-01	296	0
K172592	CADD Yellow High Volume Administration Set with NRFit connec	Smiths Medical Asd, Inc.	2018-05-17	261	0
K173912	BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselec	Smiths Medical Asd, Inc.	2018-05-08	137	1
K171968	EchoGlo Needle	Smiths Medical Asd, Inc.	2018-01-25	209	0
K170720	Portex Blue Line Ultra Paediatric Tracheosomy Tube	Smiths Medical Asd, Inc.	2017-12-07	273	0
K172458	HemoDraw Plus Closed Blood Sampling System with LogiCal Tran	Smiths Medical Asd, Inc.	2017-11-09	87	0
K162219	CADD® Infusion Disposables Portfolio with NRFit™ connectors	Smiths Medical Asd, Inc.	2017-07-20	346	1
K163172	HemoDraw Plus Closed Blood Sampling System with LogiCal Tran	Smiths Medical Asd, Inc.	2017-05-24	191	0
K160235	ViaValve Safety I.V. Catheter	Smiths Medical Asd, Inc.	2016-06-30	150	0
K141193	MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHA	Smiths Medical Asd, Inc.	2014-07-25	78	0
K130394	CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0	Smiths Medical Asd, Inc.	2013-12-09	297	2
K111275	CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDIC	Smiths Medical Asd, Inc.	2013-02-01	637	6
K110053	CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INF	Smiths Medical Asd, Inc.	2012-09-14	616	0
K121525	PERIFUSE CATHETER	Smiths Medical Asd, Inc.	2012-08-02	71	0
K113700	VIAVALVE SAFETY IV CATHETER	Smiths Medical Asd, Inc.	2012-03-14	89	0
K092256	THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC700	Smiths Medical Asd, Inc.	2010-10-20	449	0
K093414	PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS	Smiths Medical Asd, Inc.	2010-03-01	119	1
K092657	EPIFUSE CATHETER CONNECTOR, MODEL: 4909E	Smiths Medical Asd, Inc.	2009-11-04	68	0
K083031	PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT	Smiths Medical Asd, Inc.	2009-08-18	312	0
K083119	PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5,	Smiths Medical Asd, Inc.	2009-06-26	247	0
K083336	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLAN	Smiths Medical Asd, Inc.	2009-06-03	203	0
K090261	PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEED	Smiths Medical Asd, Inc.	2009-05-01	87	0
K083451	PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD	Smiths Medical Asd, Inc.	2009-03-04	103	0
K083641	BIVONA TRACHEOSTOMY TUBES	Smiths Medical Asd, Inc.	2009-02-23	76	1
K081440	BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOM	Smiths Medical Asd, Inc.	2008-09-12	113	0
K081086	PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE	Smiths Medical Asd, Inc.	2008-08-13	119	0
K081229	SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE,	Smiths Medical Asd, Inc.	2008-07-21	82	0
K072080	NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NOR	Smiths Medical Asd, Inc.	2008-06-02	308	0
K073188	HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE	Smiths Medical Asd, Inc.	2008-02-08	87	0
K072783	SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE,	Smiths Medical Asd, Inc.	2007-11-30	60	0
K072482	HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY	Smiths Medical Asd, Inc.	2007-11-29	86	0
K071958	THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB	Smiths Medical Asd, Inc.	2007-11-21	128	0
K072419	ADVANTIV SAFETY I.V. CATHETER	Smiths Medical Asd, Inc.	2007-11-09	73	0
K071785	HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-	Smiths Medical Asd, Inc.	2007-08-02	31	0
K071269	HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM	Smiths Medical Asd, Inc.	2007-08-01	86	0
K070340	SECURE ARTERIAL BLOOD SAMPLING SYSTEM	Smiths Medical Asd, Inc.	2007-03-15	37	0
K063755	PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE	Smiths Medical Asd, Inc.	2007-02-27	70	6
K063450	PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401	Smiths Medical Asd, Inc.	2007-01-25	71	0
K062005	PORTEX EPIDURAL CATHETER	Smiths Medical Asd, Inc.	2006-10-18	93	1
K061194	PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 4	Smiths Medical Asd, Inc.	2006-08-24	118	0
K061513	LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY	Smiths Medical Asd, Inc.	2006-08-01	61	0
K051524	LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE,	Smiths Medical Asd, Inc.	2005-07-07	29	0
K050314	AQUINOX	Smiths Medical Asd, Inc.	2005-02-18	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