ClearanceBrief
Company · US

Smiths Medical ASD, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2024. Name variants (Inc, Corp, punctuation) are merged.

52510(k) clearances (0 in 12 months)
474recalls (0 in 12 months)
307recalls that name a 510(k)

Product codes

CodeDeviceRecords
CAZAnesthesia Conduction Kit88
BTOTube, Tracheostomy (W/Wo Connector)56
FRNPump, Infusion43
JKATubes, Vials, Systems, Serum Separators, Blood Collection34
JOHTube Tracheostomy And Tube Cuff31
FPASet, Administration, Intravascular26
DPTProbe, Blood-Flow, Extravascular22
DRSTransducer, Blood-Pressure, Extravascular20
LJTPort & Catheter, Implanted, Subcutaneous, Intravascular19
LGZWarmer, Thermal, Infusion Fluid14
MEAPump, Infusion, Pca14
BTRTube, Tracheal (W/Wo Connector)12
DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)12
FMGStopcock, I.V. Set12
FMINeedle, Hypodermic, Single Lumen12
MEGSyringe, Antistick9
BTLVentilator, Emergency, Powered (Resuscitator)7
BYDCondenser, Heat And Moisture (Artificial Nose)6
DWJSystem, Thermal Regulating6
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days6

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 31, 2024K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
Smiths Medical Asd, Inc.
QNQ
Nov 26, 2021K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheo
Smiths Medical Asd, Inc.
JOH
Aug 26, 2021K211634Hypodermic Needle-Pro EDGE Safety Device
Smiths Medical Asd, Inc.
FMI
Sep 18, 2020K192375Intellifuse Administration and Intellifuse Blood Administration Sets
Smiths Medical Asd, Inc.
FPA
Jul 26, 2018K181699Level 1 Convective Warmer
Smiths Medical Asd, Inc.
DWJ
Jun 14, 2018K172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors
Smiths Medical Asd, Inc.
MIA
Jun 12, 2018K172823Portex NRFit Epidural Needles
Smiths Medical Asd, Inc.
BSP
Jun 1, 2018K172410Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex E
Smiths Medical Asd, Inc.
BSP
May 17, 2018K172592CADD Yellow High Volume Administration Set with NRFit connector
Smiths Medical Asd, Inc.
PWH
May 8, 2018K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with
Smiths Medical Asd, Inc.
JOH
Jan 25, 2018K171968EchoGlo Needle
Smiths Medical Asd, Inc.
BSP
Dec 7, 2017K170720Portex Blue Line Ultra Paediatric Tracheosomy Tube
Smiths Medical Asd, Inc.
JOH
Nov 9, 2017K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with
Smiths Medical Asd, Inc.
DRS
Jul 20, 2017K162219CADD® Infusion Disposables Portfolio with NRFit™ connectors
Smiths Medical Asd, Inc.
PWH
May 24, 2017K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with
Smiths Medical Asd, Inc.
DRS
Jun 30, 2016K160235ViaValve Safety I.V. Catheter
Smiths Medical Asd, Inc.
FOZ
Jul 25, 2014K141193MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0
Smiths Medical Asd, Inc.
PHC
Dec 9, 2013K130394CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
Smiths Medical Asd, Inc.
MEA
Feb 1, 2013K111275CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
Smiths Medical Asd, Inc.
FRN
Sep 14, 2012K110053CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
Smiths Medical Asd, Inc.
CAZ
Aug 2, 2012K121525PERIFUSE CATHETER
Smiths Medical Asd, Inc.
CAZ
Mar 14, 2012K113700VIAVALVE SAFETY IV CATHETER
Smiths Medical Asd, Inc.
FOZ
Oct 20, 2010K092256THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
Smiths Medical Asd, Inc.
BTT
Mar 1, 2010K093414PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
Smiths Medical Asd, Inc.
LJT
Nov 4, 2009K092657EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
Smiths Medical Asd, Inc.
CAZ
Aug 18, 2009K083031PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
Smiths Medical Asd, Inc., GB
BTO
Jun 26, 2009K083119PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
Smiths Medical Asd, Inc., GB
BTR
Jun 3, 2009K083336LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL
Smiths Medical Asd, Inc.
DWJ
May 1, 2009K090261PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G
Smiths Medical Asd, Inc.
BSP
Mar 4, 2009K083451PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS
Smiths Medical Asd, Inc.
BSN
Feb 23, 2009K083641BIVONA TRACHEOSTOMY TUBES
Smiths Medical Asd, Inc.
JOH
Sep 12, 2008K081440BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
Smiths Medical Asd, Inc.
JOH
Aug 13, 2008K081086PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0
Smiths Medical Asd, Inc., GB
BTR
Jul 21, 2008K081229SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING
Smiths Medical Asd, Inc.
JKA
Jun 2, 2008K072080NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
Smiths Medical Asd, Inc.
LGZ
Feb 8, 2008K073188HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
Smiths Medical Asd, Inc.
FMI
Nov 30, 2007K072783SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH
Smiths Medical Asd, Inc.
JKA
Nov 29, 2007K072482HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
Smiths Medical Asd, Inc.
MEG
Nov 21, 2007K071958THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS
Smiths Medical Asd, Inc.
BTT
Nov 9, 2007K072419ADVANTIV SAFETY I.V. CATHETER
Smiths Medical Asd, Inc.
FOZ
Aug 2, 2007K071785HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE
Smiths Medical Asd, Inc.
FMI
Aug 1, 2007K071269HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
Smiths Medical Asd, Inc.
CBT
Mar 15, 2007K070340SECURE ARTERIAL BLOOD SAMPLING SYSTEM
Smiths Medical Asd, Inc.
CBT
Feb 27, 2007K063755PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
Smiths Medical Asd, Inc.
MEG
Jan 25, 2007K063450PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110
Smiths Medical Asd, Inc.
FMI
Oct 18, 2006K062005PORTEX EPIDURAL CATHETER
Smiths Medical Asd, Inc.
BSO
Aug 24, 2006K061194PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
Smiths Medical Asd, Inc.
MEG
Aug 1, 2006K061513LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
Smiths Medical Asd, Inc.
DWJ
Jul 7, 2005K051524LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
Smiths Medical Asd, Inc.
BSO
Feb 18, 2005K050314AQUINOX
Smiths Medical Asd, Inc.
BTT

Newest 50 of 52.

Latest recalls

DateFirm and productCodeLinked 510(k)
May 7, 2025Smiths Medical ASD, Inc.
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HP
Open, Classified
MEAK170982
May 7, 2025Smiths Medical ASD, Inc.
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-
Open, Classified
FRNK111275
May 7, 2025Smiths Medical ASD, Inc.
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLI
Open, Classified
MEAK072144
K130394 +1
May 5, 2025Smiths Medical ASD, Inc.
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLI
Open, Classified
FRNK111275
May 5, 2025Smiths Medical ASD, Inc.
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA,
Open, Classified
MEAK170982
Mar 20, 2025Smiths Medical ASD, Inc.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Open, Classified
CCKK941982
Mar 20, 2025Smiths Medical ASD, Inc.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Open, Classified
CCKK871133
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
Open, Classified
LJTK994216
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
Open, Classified
LJTK994216
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Open, Classified
LJTNone listed
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
Open, Classified
LJTNone listed
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
Open, Classified
LJTNone listed
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
Open, Classified
LJTK994216
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
Open, Classified
LJTK994216
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
Open, Classified
LJTK994216
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
Open, Classified
LJTK994216
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
Open, Classified
LJTNone listed
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
Open, Classified
LJTNone listed
Mar 18, 2025Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Open, Classified
LJTNone listed
Mar 12, 2025Smiths Medical ASD, Inc.
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127
Open, Classified
BTRK790312
Nov 25, 2024Smiths Medical ASD, Inc.
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
Open, Classified
BSRNone listed
Nov 25, 2024Smiths Medical ASD, Inc.
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Open, Classified
BSRNone listed
Nov 25, 2024Smiths Medical ASD, Inc.
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
Open, Classified
BSRNone listed
Nov 15, 2024Smiths Medical ASD, Inc.
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
Open, Classified
MEAK111275
K170982
Oct 31, 2024Smiths Medical ASD Inc.
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-020
Open, Classified
FRNK111275
Oct 23, 2024Smiths Medical ASD Inc.
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Open, Classified
BYDNone listed
Oct 23, 2024Smiths Medical ASD Inc.
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Open, Classified
BYDNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex Arterial Kit 1/EA, Product Code REF MX7827
Open, Classified
DPTNone listed
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
Open, Classified
DPTK942377
Oct 23, 2024Smiths Medical ASD, Inc.
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Open, Classified
DPTK942377
Oct 23, 2024Smiths Medical ASD, Inc.
medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
Open, Classified
DPTK942377
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar Single ICP Set 1/EA, Product Code REF MX20897
Open, Classified
GWMK020780

Newest 50 of 474.

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