4LYF Oxygen Concentrator
FDA 510(k) K872534 · Airsep Corp.
510(k) numberK872534
Submission
- Device name
- 4LYF Oxygen Concentrator
- Applicant
- Airsep Corp.
Buffalo, NY, US - Received
- June 26, 1987
- Decision date
- October 13, 1987
- 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 |
|---|---|---|
| K150930 | Deployable Oxygen Generation System-Smaill (DOGS-S)CAW · Traditional | 12/18/2015SE |
| K101154 | Centrox, Reliant, Ultrox, As-D+, As-E, As-G, As-J, As-K and As-LCAW · Traditional | 03/28/2011SE |
| K080348 | Oxiscan II Data Management SystemDQA · Traditional | 10/09/2008SE |
| K020324 | Lifestyle Oxygen ConcentratorCAW · Traditional | 03/13/2002SE |
| K012037 | Healthlife Oxygen Concentrator Model AS009CAW · Traditional | 01/17/2002SE |
| K000963 | Da Vinchi EEG and Emg/Ep SystemsGWF · Traditional | 10/20/2000SE |
| K001579 | Impulse SelectNFB · Traditional | 08/31/2000SE |
| K001467 | Da Vinchi Emg/Ep ISA1004EPGWE · Traditional | 08/01/2000SE |
| K001013 | Monet Acquisition System for EEG and PolysomnographyOLV · Traditional | 05/16/2000SE |
| K992283 | Artisan Acquisition System for EEG and PolysomnographyOLV · Traditional | 08/27/1999SE |
Questions and answers
When was 4LYF Oxygen Concentrator cleared by the FDA?
4LYF Oxygen Concentrator (K872534) received a 510(k) decision of Substantially Equivalent on October 13, 1987, 109 days after the submission was received.
What is the product code of K872534?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.