EasyCare Tx 2
FDA 510(k) K261360 · Resmed Corp
510(k) numberK261360
Submission
- Device name
- EasyCare Tx 2
- Applicant
- Resmed Corp
San Diego, CA, US - Received
- April 24, 2026
- Decision date
- August 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOD – Accessory To Continuous Ventilator (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
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| K242485 | EveryWareMOD · Traditional | Breas Medical AB | 05/20/2025SE |
| K161411 | Care Cycle Connect ApplicationMOD · Traditional | Respironics, Inc. | 02/17/2017SE |
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| K052751 | Ventlink SystemMOD · Traditional | Mediserve Information Systems, Inc. | 12/23/2005SE |
| K052244 | Iisis, Version 1.0MOD · Traditional | Innovision Medical Technologies, LLC | 10/13/2005SE |
| K040712 | Air Safety Hepa, Model 3500MOD · Traditional | Air Safety, Ltd. | 06/03/2004SE |
| K022062 | Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00MOD · Abbreviated | Impact Instrumentation, Inc. | 05/06/2003SE |
| K010401 | Tri-Plex AdapterMOD · Traditional | The Medical Device Group, Inc. | 10/30/2002SE |
More from The Medical Device Group, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K200565 | GalapogosBZD · Traditional | 01/17/2021SE |
Questions and answers
When was EasyCare Tx 2 cleared by the FDA?
EasyCare Tx 2 (K261360) received a 510(k) decision of Substantially Equivalent on August 27, 2026, 125 days after the submission was received.
What is the product code of K261360?
The FDA product code is MOD – Accessory To Continuous Ventilator (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5895.