Purefill Oxygen Compressor
FDA 510(k) K141967 · Inovo, Inc.
510(k) numberK141967
Submission
- Device name
- Purefill Oxygen Compressor
- Applicant
- Inovo, Inc.
Lehigh Acres, FL, US - Received
- July 21, 2014
- Decision date
- November 7, 2014
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionNFB · Special | 12/08/2011SE |
| K103392 | Chad Therapeutic Evolution Electronic Oxygen ConserverNFB · Special | 12/17/2010SE |
| K060751 | Inovo, Inc. Accupulse Single Lumen Conserving RegulatorNFB · Traditional | 07/18/2006SE |
| K051540 | Inovo, Inc. Independence Oxygen Conserving RegulatorNFB · Traditional | 09/21/2005SE |
| K031983 | Inovo, Inc, Economizer Conserving RegulatorNFB · Traditional | 09/15/2003SE |
Questions and answers
When was Purefill Oxygen Compressor cleared by the FDA?
Purefill Oxygen Compressor (K141967) received a 510(k) decision of Substantially Equivalent on November 7, 2014, 109 days after the submission was received.
What is the product code of K141967?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.