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)
Top companies in BYG
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2026 | Medline 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 |
BYG | None listed |
| Jul 11, 2018 | POM 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 |
BYG | None listed |
| May 24, 2017 | ConvaTec, 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 |
BYG | None listed |
| May 24, 2017 | ConvaTec, 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 |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106 Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, 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 |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, 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 |
BYG | None listed |
| May 24, 2017 | ConvaTec, 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 |
BYG | None listed |
| May 24, 2017 | ConvaTec, 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 |
BYG | None listed |
| May 24, 2017 | ConvaTec, 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 |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001 Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, 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 |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E; Terminated |
BYG | None listed |
| Apr 3, 2017 | Intersurgical 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 |
BYG | None listed |
| Jul 23, 2014 | Salter 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 |
BYG | None listed |
| Oct 26, 2011 | Salter 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 |
BYG | None listed |
| Oct 26, 2011 | Salter 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 |
BYG | None listed |
| Oct 26, 2011 | Salter 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 |
BYG | None listed |
| Jun 29, 2011 | Vital 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 |
BYG | None listed |
| Jun 24, 2011 | Smiths 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 |
BYG | None listed |
| Jun 24, 2011 | Smiths 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 |
BYG | None listed |
| Jun 24, 2011 | Smiths 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 |
BYG | None listed |
| Jun 24, 2011 | Smiths 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 |
BYG | None listed |
| Jun 24, 2011 | Smiths 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 |
BYG | None listed |
| Jun 24, 2011 | Smiths 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 |
BYG | None listed |
| Jun 24, 2011 | Smiths 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 |
BYG | None listed |
| Jun 24, 2011 | Smiths 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 |
BYG | None listed |
| Apr 6, 2011 | King 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 |
BYG | None listed |
| Apr 6, 2011 | King 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 |
BYG | None listed |
| Apr 6, 2011 | King 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 |
BYG | None listed |
| Apr 6, 2011 | King 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 |
BYG | None listed |
| Apr 6, 2011 | King 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 |
BYG | None listed |
| Apr 6, 2011 | King 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 |
BYG | None listed |
| Feb 15, 2011 | Convatec 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 |
BYG | None listed |
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