FreeStyle Comfort (AS200 / FreeStyle Comfort)
FDA 510(k) K250671 · Caire, Inc.
510(k) numberK250671
Submission
- Device name
- FreeStyle Comfort (AS200 / FreeStyle Comfort)
- Applicant
- Caire, Inc.
Ball Ground, GA, US - Received
- March 5, 2025
- Decision date
- July 11, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K120785 | Omni 3 Oxygen SystemCAW · Special | 10/25/2012SE |
| K121167 | Caire Companion 5 Oxygen ConcentratorCAW · Traditional | 05/02/2012SE |
| K080023 | Modification to: SpiritBYJ · Special | 06/16/2008SE |
| K050153 | Spirit, Model HasBYJ · Traditional | 04/15/2005SE |
| K013251 | Spirit 300BYJ · Traditional | 12/18/2001SE |
| K952268 | Model Delta, Om Oxygen ConcentratorCAW · Traditional | 08/11/1995SE |
Questions and answers
When was FreeStyle Comfort (AS200 / FreeStyle Comfort) cleared by the FDA?
FreeStyle Comfort (AS200 / FreeStyle Comfort) (K250671) received a 510(k) decision of Substantially Equivalent on July 11, 2025, 128 days after the submission was received.
What is the product code of K250671?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.