Panels › Anesthesiology › Product code BYE · Class 2
Attachment, Breathing, Positive End Expiratory Pressure
Regulation 868.5965
0510(k)s in 12 months (80 all time)
1recalls in 12 months (11 all time)
7recalls that name a 510(k)
Top companies in BYE
| Company | 510(k)s | Recalls |
|---|---|---|
| Ambu, Inc. | 2 | 4 |
| Puritan Bennett Corp. | 6 | 0 |
| Vital Signs, Inc. | 6 | 0 |
| Respironics, Inc. | 5 | 0 |
| Draeger Medical AG & Co. KG | 4 | 0 |
| Devilbiss Health Care, Inc. | 3 | 0 |
| Life Design Systems, Inc. | 3 | 0 |
| Westmed, Inc. | 0 | 3 |
| Airways Development, LLC | 1 | 1 |
| Engineered Medical Systems | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | Draeger, Inc. VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310
Disposable breathing circuit for use with a resuscitation module. Open, Classified |
BYE | K092029 |
| Jan 15, 2019 | Westmed, Inc. Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only. Terminated |
BYE | K923618 |
| Jan 15, 2019 | Westmed, Inc. Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only. Terminated |
BYE | K923618 |
| Jan 15, 2019 | Westmed, Inc. Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only. Terminated |
BYE | K923618 |
| Dec 24, 2015 | Airways Development LLC Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700. Terminated |
BYE | K110713 |
| Jul 16, 2008 | Smiths Medical ASD, Inc. Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing attachment; Reference Number: P63000; Smiths Medical, Rockland, MA 02370. Terminated |
BYE | K854822 |
| Jul 16, 2008 | Smiths Medical ASD, Inc. Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370. Terminated |
BYE | None listed |
| Dec 22, 2007 | Ambu Incorporated Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, REF 137 000 501, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 Terminated |
BYE | None listed |
| Dec 22, 2007 | Ambu Incorporated Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, REF 137 001 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthi Terminated |
BYE | None listed |
| Dec 22, 2007 | Ambu Incorporated Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-135 Terminated |
BYE | None listed |
| Dec 22, 2007 | Ambu Incorporated Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 Terminated |
BYE | K782152 |
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