Portable Oxygen Generator
FDA 510(k) K884084 · Mountain Medical Equipment, Inc.
510(k) numberK884084
Submission
- Device name
- Portable Oxygen Generator
- Applicant
- Mountain Medical Equipment, Inc.
Littleton, CO, US - Received
- September 27, 1988
- Decision date
- November 21, 1988
- 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 |
|---|---|---|
| K941793 | Oxygen Concentration Status Indicator (O.C.S.I.)CCL · Traditional | 06/21/1995SE |
| K923650 | ScottyCAW · Traditional | 01/15/1993SE |
| K924684 | MicroflowCAF · Traditional | 12/15/1992SE |
| K914916 | Alpine VCAW · Traditional | 09/23/1992SE |
| K902890 | Aspen 3 Oxygen ConcentratorCAW · Traditional | 07/19/1990SE |
| K893531 | Cuff SpeculumKPL · Traditional | 06/22/1989SE |
| K881802 | Alpine Portable Oxygen GeneratorCAW · Traditional | 07/08/1988SE |
| K873677 | Econo-Mist Portable Compressor Driven NebulizerBTI · Traditional | 10/20/1987SE |
| K873170 | AriesBYE · Traditional | 09/25/1987SE |
| K864005 | AlpineCAW · Traditional | 01/28/1987SE |
Questions and answers
When was Portable Oxygen Generator cleared by the FDA?
Portable Oxygen Generator (K884084) received a 510(k) decision of Substantially Equivalent on November 21, 1988, 55 days after the submission was received.
What is the product code of K884084?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.