Easycare Online
FDA 510(k) K123557 · Resmed, Ltd.
510(k) numberK123557
Submission
- Device name
- Easycare Online
- Applicant
- Resmed, Ltd.
San Diego, CA, US - Received
- November 19, 2012
- Decision date
- March 14, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNS – Ventilator, Continuous, Non-Life-Supporting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
Other 510(k)s with product code MNS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251889 | myAirMNS · Traditional | Resmed Corp | 04/08/2026SE |
| K252078 | BreathePal Bilevel (GFM50-MD2201)MNS · Traditional | Compal Electronics, Inc. | 03/17/2026SE |
| K251661 | Mariana Minerva; Mariana NimbusMNS · Traditional | Resmed Pty , Ltd. | 02/23/2026SE |
| K240778 | Vivo 1, Vivo 2MNS · Traditional | Breas Medical AB | 12/13/2024SE |
| K231064 | ReddyPort ElbowMNS · Traditional | Smd Manufacturing, LLC | 07/13/2023SE |
| K213169 | BPAP SystemMNS · Traditional | BMC Medical Co., Ltd. | 12/05/2022SE |
| K171827 | ReddyPort NIV Access ElbowMNS · Traditional | Smd Manufacturing, LLC | 01/19/2018SE |
| K161492 | Juno VPAP ST-AMNS · Traditional | Resmed, Ltd. | 01/19/2017SE |
| K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP TxMNS · Traditional | Resmed, Ltd. | 09/09/2016SE |
| K153061 | Juno VPAP ST-AMNS · Traditional | Resmed, Ltd. | 04/13/2016SE |
More from Resmed, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261360 | EasyCare Tx 2MOD · Traditional | 08/27/2026SE |
| K253553 | OrionBZD · Traditional | 06/04/2026SE |
| K254104 | ResScan EssentialsBZD · Traditional | 05/27/2026SE |
| K251889 | myAirMNS · Traditional | 04/08/2026SE |
| K251661 | Mariana Minerva; Mariana NimbusMNS · Traditional | 02/23/2026SE |
| K251657 | Personalized Therapy Comfort Settings (PTCS)BZD · Traditional | 12/05/2025SE |
| K250624 | myAirBZD · Traditional | 05/28/2025SE |
| K242547 | AirFit F20 Mask System; AirFit F20 NM Mask SystemBZD · Traditional | 05/19/2025SE |
| K241939 | EasyCare Tx 2BZD · Traditional | 09/27/2024SE |
| K241216 | myAirBZD · Traditional | 09/26/2024SE |
Questions and answers
When was Easycare Online cleared by the FDA?
Easycare Online (K123557) received a 510(k) decision of Substantially Equivalent on March 14, 2013, 115 days after the submission was received.
What is the product code of K123557?
The FDA product code is MNS – Ventilator, Continuous, Non-Life-Supporting, a Class II (moderate risk) device regulated under 21 CFR 868.5895.