Portable Oxygen Generator
FDA 510(k) K915381 · Aequitron Medical, Inc.
510(k) numberK915381
Submission
- Device name
- Portable Oxygen Generator
- Applicant
- Aequitron Medical, Inc.
Plymouth, MN, US - Received
- November 29, 1991
- Decision date
- March 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K961972 | Model Ami Infant Central Aphea/Heart Rate MonitorBZQ · Traditional | 04/18/1997ST |
| K952880 | Model LP-1000 Volume VentilatorCBK · Traditional | 06/20/1996ST |
| K944654 | Oxygen Concentration IndicatorCCL · Traditional | 11/08/1994SE |
| K914424 | Model 6213 Remote AlarmCBK · Traditional | 09/10/1992SE |
| K911399 | Nasal CPAP (Continuous Positive Air Pressure Syst)DZD · Traditional | 09/19/1991SE |
| K903020 | Respiration/Heart Rate Monitor Model 9500/9550BZQ · Traditional | 04/10/1991SE |
| K905244 | Model LP6 Ventilator, ModificationCBK · Traditional | 11/30/1990SE |
| K903010 | Continuous Volume Ventilator Model LP10CBK · Traditional | 11/30/1990SE |
| K902785 | Modified Models 9500,9550,9200,8200,HEART Rate MonBZQ · Traditional | 07/13/1990SE |
| K901656 | Model 9200 Respiration/Heart Rate MonitorBZQ · Traditional | 07/13/1990SE |
Questions and answers
When was Portable Oxygen Generator cleared by the FDA?
Portable Oxygen Generator (K915381) received a 510(k) decision of Substantially Equivalent on March 11, 1992, 103 days after the submission was received.
What is the product code of K915381?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.