John Bunn: Medix Compact Traveller
FDA 510(k) K900854 · The John Bunn Co.
510(k) numberK900854
Submission
- Device name
- John Bunn: Medix Compact Traveller
- Applicant
- The John Bunn Co.
Tonawanda, NY, US - Received
- February 22, 1990
- Decision date
- April 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
Other 510(k)s with product code BTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262268 | Optiflow Oxygen Kit (AA484J)BTT · Special | Fisher and Paykel Healthcare Limited | 08/27/2026SE |
| K254078 | HVT 2.0BTT · Traditional | Vapotherm, Inc. | 04/13/2026SE |
| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | Flexicare Medical Limited. | 01/16/2026SE |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/14/2026SE |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special | Fisher & Paykel Healthcare, Ltd. | 12/19/2025SE |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | Medline Industries, LP | 07/02/2025SE |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special | Fisher & Paykel Healthcare, Ltd. | 06/25/2025SE |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/30/2025SE |
| K241778 | Hudson RCI Comfort Flo® CubCannulaBTT · Traditional | Medline Industries, LP | 12/19/2024SE |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional | Medline Industries, LP | 09/27/2024SE |
More from Medline Industries, LP
| 510(k) | Device | Decision |
|---|---|---|
| K883216 | Bunn Model 50 Oxygen Flow ControllerNFB · Traditional | 08/18/1988SE |
| K873071 | Bunn Concentrator Model 2100 SeriesCAW · Traditional | 09/15/1987SE |
| K870094 | Bunn Model 530 AspiratorBTA · Traditional | 03/06/1987SE |
| K861435 | Bunn Concentrator Model 2011 with Demand ValveCAW · Traditional | 11/07/1986SE |
| K861199 | Bunn Model 22 Oxygen Flow ControllerNFB · Traditional | 08/26/1986SE |
| K862628 | Bunn Model 510 Medication CompressorBTI · Traditional | 08/07/1986SE |
| K855208 | Bunn Lite Oxygen ConcentratorCAW · Traditional | 02/21/1986SE |
| K860060 | RX02 Plus Oxygen ConcentratorCAW · Traditional | 02/05/1986SE |
| K843811 | Bunn 3001 Oxygen ConcentratorCAW · Traditional | 10/04/1984SE |
| K841102 | Bunn 1000 Oxygen ConcentratorCAW · Traditional | 04/13/1984SE |
Questions and answers
When was John Bunn: Medix Compact Traveller cleared by the FDA?
John Bunn: Medix Compact Traveller (K900854) received a 510(k) decision of Substantially Equivalent on April 23, 1990, 60 days after the submission was received.
What is the product code of K900854?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.