ClearanceBrief
Panels › Anesthesiology › Product code BYG · Class 1

Mask, Oxygen

Regulation 868.5580

0510(k)s in 12 months (55 all time)
1recalls in 12 months (41 all time)
0recalls that name a 510(k)
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Top companies in BYG

DateFirm and productCodeLinked 510(k)
Jan 8, 2026Medline Industries, LP
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 M
Open, Classified
BYGNone listed
Jul 11, 2018POM Medical LLC
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA;
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Terminated
BYGNone listed
Apr 3, 2017Intersurgical Inc
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalo
Terminated
BYGNone listed
Jul 23, 2014Salter Labs
Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.
Terminated
BYGNone listed
Oct 26, 2011Salter Laboratories, Division of Regulatory Affairs
Mask adult, oxygen, medium concentration, elastic strap style, w/9' tube - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.
Terminated
BYGNone listed
Oct 26, 2011Salter Laboratories, Division of Regulatory Affairs
Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/9' tube and safety vent - 50/cs; Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w safety
Terminated
BYGNone listed
Oct 26, 2011Salter Laboratories, Division of Regulatory Affairs
Mask adult, oxygen, medium concentration, elastic strap style w. 7' tube (Linde) 50/cs Mask, adult, oxygen, high concentration, non-rebreathing, elastic strap style w/ 7' tube and safety vent - 50/c
Terminated
BYGNone listed
Jun 29, 2011Vital Signs Devices, a GE Healthcare Company
Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA The kit contains oxygen masks and blood pressure cuffs use on pediatric patients
Terminated
BYGNone 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
Apr 6, 2011King Systems Corp.
Universal F Anesthesia Breathing Circuit, REF 5U345-611XB, Manufacturer: King Systems, Nobleville, IN. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administ
Terminated
BYGNone listed
Apr 6, 2011King Systems Corp.
Universal F2 Anesthesia Breathing Circuit, REF 5D440-61X-17, Manufacturer: King Systems, Nobleville, IN. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to admini
Terminated
BYGNone listed
Apr 6, 2011King Systems Corp.
Aerosol mask with 15 mm adapter, REF S-MD127, Manufacturer: King Systems, Nobleville, IN. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or
Terminated
BYGNone listed
Apr 6, 2011King Systems Corp.
Aerosol Mask with 15 mm Adapter, REF MD127, Manufacturer: King Systems, Nobleville, IN. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or ae
Terminated
BYGNone listed
Apr 6, 2011King Systems Corp.
Face Tent with 15 mm Adapter, REF S-MD126, Manufacturer: King Systems Nobleville, IN. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aeroso
Terminated
BYGNone listed
Apr 6, 2011King Systems Corp.
Face Tent with 15 mm Adapter, REF MD126, Manufacturer: King Systems Nobleville, IN. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols
Terminated
BYGNone listed
Feb 15, 2011Convatec Inc.
Oxygen Masks- Labeling as follows: MADA, Inc. Adult Medium Concentration Oxygen Mask with Non-crush 7 Coiled Tubing, Connector Both Ends No 1327; RESPIREX Aerosol Mask Adult Elongated Manufactured
Terminated
BYGNone listed

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