ClearanceBrief
Company ยท GB

Smiths Medical

FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2019. Name variants (Inc, Corp, punctuation) are merged.

3510(k) clearances (0 in 12 months)
27recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
BTRTube, Tracheal (W/Wo Connector)17
BYGMask, Oxygen8
BYFMask, Oxygen, Low Concentration, Venturi2
BWCNeedle, Emergency Airway1
BWFSpirometer, Therapeutic (Incentive)1
JOHTube Tracheostomy And Tube Cuff1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 24, 2019K181660Acapella Choice Blue Vibratory PEP Device
Smiths Medical
BWF
May 26, 2005K050166PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
Smiths Medical, GB
BWC
Jul 13, 2004K041348PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
Smiths Medical, GB
JOH

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 24, 2011Smiths Medical
Value Pack General Anesthesia Kit, (containing Reorder Number: 001421 Oxygen Face Mask) Reorder Number: VP1302 For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patient
Terminated
BYFNone listed
Jun 24, 2011Smiths Medical
First Breath Adult Venturi Oxygen Mask with Corrugated Tubing, O2 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-latex) 50/CA Reorder Number: 002610 For acute use, e.g. Post-op recovery, m
Terminated
BYFNone listed
Jun 24, 2011Smiths Medical
First Breath Adult Face Tent with Tubing 188cm (5ft.) (Non-latex) Reorder Number: 001492 Face Tent Is a special type of aerosol mask used when the delivery of oxygen is not the primary objective. Nor
Terminated
BYGNone listed
Jun 24, 2011Smiths Medical
First Breath Adult Face Tent (Non-latex) 50/CA Reorder Number: 001490 Face Tent Is a special type of aerosol mask used when the delivery of oxygen is not the primary objective. Normally this type of
Terminated
BYGNone listed
Jun 24, 2011Smiths Medical
First Breath Pediatric Aerosol Mask (Non-Latex) 50/CA Reorder Number: 001476 For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is de
Terminated
BYGNone listed
Jun 24, 2011Smiths Medical
First Breath PEDIATRIC Medium Concentration Oxygen Mask with Tubing, 213cm (7ft) (Non-latex) 50/CA Reorder Number: 001471 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, pat
Terminated
BYGNone listed
Jun 24, 2011Smiths Medical
First Breath ADULT Elongated Non-Rebreather Oxygen Mask with 1L Reservoir Bag & Tubing, 213cm (7ft.) 50/CA Reorder Number: 001431 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal tr
Terminated
BYGNone listed
Jun 24, 2011Smiths Medical
First Breath Adult Aerosol Mask (Non-latex) 50/CA Reorder Number: 001426 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more
Terminated
BYGNone listed
Jun 24, 2011Smiths Medical
First Breath 3 in 1 Oxygen Mask with Reservoir Bag (1L) and Tubing, 213cm (7ft) (Non-latex) 50/CA Re-Order Number: 001423 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, pa
Terminated
BYGNone listed
Jun 24, 2011Smiths Medical
First Breath Adult Oxygen Mask with Tubing, 213cm (7ft) Reorder Number: 001421 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring
Terminated
BYGNone listed
Sep 18, 2009Smiths Medical
Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.5 mm Product Code: 100/134/035. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.0 mm Product Code: 100/134/030. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.5 mm Product Code: 100/127/035. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.0 mm Product Code: 100/127/030. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 2.5 mm Product Code: 100/127/025. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.5 mm Product Code: 100/141/035. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.0 mm Product Code: 100/141/030. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 2.5 mm Product Code: 100/141/025. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 3.5 mm Product Code: 100/126/035. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 3.0 mm Product Code: 100/126/030. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 2.5 mm Product Code: 100/126/025. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Tracheal Tube, Oral/Nasal, Siliconized, 3.5 mm Product Code: 100/111/035. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Tracheal Tube, Oral/Nasal, Siliconized, 3.0 mm Product Code: 100/111/030. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Tracheal Tube, Oral/Nasal, Siliconized, 2.5 mm Product Code: 100/111/025. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Uncuffed Paediatric Sized Tracheal Tube Oral Nasal, Ivory 3.5 mm, Product Code: 100/105/035. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Uncuffed Paediatric Sized Tracheal Tube Oral Nasal, Ivory 3.0 mm, Product Code: 100/105/030. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Uncuffed Paediatric Sized Tracheal Tube, Oral Nasal , Ivory 2.5 mm, Product Code: 100/105/025. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed
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