Oxygen Concentrator
FDA 510(k) K924100 · Allied Healthcare Products, Inc.
510(k) numberK924100
Submission
- Device name
- Oxygen Concentrator
- Applicant
- Allied Healthcare Products, Inc.
Saint Louis, MO, US - Received
- August 13, 1992
- Decision date
- March 19, 1993
- 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 |
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| K090356 | Emergency Portable Ventilator, Model EPV200BTL · Traditional | 05/20/2009SE |
| K083507 | Battery Pack for MCV100 and MCV200 Emergency VentilatorsBTL · Traditional | 05/18/2009SE |
| K083385 | Mass Casualty Ventilators, Models: MCV200 and MCV200-BBTL · Traditional | 05/14/2009SE |
| K080063 | Mass Casualty Ventilator, Model MCV100BTL · Traditional | 08/15/2008SE |
| K072214 | Portable Ventilator, Model EPV-100BTL · Traditional | 03/06/2008SE |
| K073171 | Resuscitation Timer, Model L770-CPRBTM · Traditional | 01/31/2008SE |
| K070636 | Autovent 4000 with CPAPBTL · Traditional | 07/13/2007SE |
| K070120 | Autovent Model 4000BTL · Traditional | 05/03/2007SE |
Questions and answers
When was Oxygen Concentrator cleared by the FDA?
Oxygen Concentrator (K924100) received a 510(k) decision of Substantially Equivalent on March 19, 1993, 218 days after the submission was received.
What is the product code of K924100?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.