Humidifier & Accessories
FDA 510(k) K953949 · Fisher & Paykel Electronics , Ltd.
510(k) numberK953949
Submission
- Device name
- Humidifier & Accessories
- Applicant
- Fisher & Paykel Electronics , Ltd.
Auckland, New Zealand, NZ - Received
- August 22, 1995
- Decision date
- October 16, 1995
- 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 |
|---|---|---|
| K973161 | CPAP Humidifier (HC 200)BZD · Traditional | 07/10/1998SE |
| K972885 | Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual Control Wall-Mount…FMT · Traditional | 10/30/1997SE |
| K971695 | Servo-Control Cosycot Infant Warmer, Manual-Control Cosycot Infant WarmerFMT · Traditional | 07/28/1997SE |
| K971461 | Servo-Control Wall-Mount Infant WARMER(IW980)/MANUAL-CONTROL Wall-Mount Infant…FMT · Traditional | 07/16/1997SE |
| K970432 | Infant Radiant Warmer - Models IW910 and IW920FMT · Traditional | 05/07/1997SE |
| K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)BTT · Traditional | 03/12/1996SE |
| K953711 | Air Entrainer 900RT008BZR · Traditional | 11/08/1995SE |
| K934140 | MR290 Humidification Chamber Single UseBTT · Traditional | 01/24/1994SE |
| K924234 | Cons. Current Periph. Nerve Loc. NS232,NS262,NS272KOI · Traditional | 05/27/1993SE |
| K915460 | Heated Respiratory Humidifier HC100BTT · Traditional | 01/15/1993SE |
Questions and answers
When was Humidifier & Accessories cleared by the FDA?
Humidifier & Accessories (K953949) received a 510(k) decision of Substantially Equivalent on October 16, 1995, 55 days after the submission was received.
What is the product code of K953949?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.