Bunn Concentrator Model 2011 with Demand Valve
FDA 510(k) K861435 · The John Bunn Co.
510(k) numberK861435
Submission
- Device name
- Bunn Concentrator Model 2011 with Demand Valve
- Applicant
- The John Bunn Co.
Tonawanda, NY, US - Received
- April 17, 1986
- Decision date
- November 7, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAW – Generator, Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5440
- Specialty
- Anesthesiology
Other 510(k)s with product code CAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B)CAW · Traditional | BMC Medical Co., Ltd. | 08/14/2026SE |
| K252399 | Portable Oxygen ConcentratorCAW · Traditional | Honsun (Nantong) Co., Ltd. | 06/17/2026SE |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C)CAW · Traditional | Oxytek Medical Technology Co., Ltd. | 05/29/2026SE |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000)CAW · Traditional | Mv Life, LLC | 04/23/2026SE |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555)CAW · Traditional | Devilbiss Healthcare, LLC | 03/26/2026SE |
| K251534 | Oxygen Concentrator (J10A)CAW · Traditional | Foshan Kycare Medical Equipment Co., Ltd. | 12/29/2025SE |
| K252616 | Portable oxygen concentrator (JLO-190P)CAW · Traditional | Shenzhen Homed Medical Device Co., Ltd. | 12/22/2025SE |
| K251764 | Oxygen Concentrator-P2-O5ECAW · Traditional | Qingdao Kingon Medical Science and Technology… | 12/22/2025SE |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C)CAW · Traditional | Shenzhen Harveymed Technology Co., Ltd. | 12/16/2025SE |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)CAW · Traditional | Devilbiss Healthcare, LLC | 12/09/2025SE |
More from Devilbiss Healthcare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K900854 | John Bunn: Medix Compact TravellerBTT · Traditional | 04/23/1990SE |
| 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 |
| 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 Bunn Concentrator Model 2011 with Demand Valve cleared by the FDA?
Bunn Concentrator Model 2011 with Demand Valve (K861435) received a 510(k) decision of Substantially Equivalent on November 7, 1986, 204 days after the submission was received.
What is the product code of K861435?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.