ResScan Essentials
FDA 510(k) K254104 · Resmed Corp
510(k) numberK254104
Submission
- Device name
- ResScan Essentials
- Applicant
- Resmed Corp
San Diego, CA, US - Received
- December 19, 2025
- Decision date
- May 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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More from Fisher & Paykel Healthcare Limited
| 510(k) | Device | Decision |
|---|---|---|
| K261360 | EasyCare Tx 2MOD · Traditional | 08/27/2026SE |
| K253553 | OrionBZD · Traditional | 06/04/2026SE |
| 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 ResScan Essentials cleared by the FDA?
ResScan Essentials (K254104) received a 510(k) decision of Substantially Equivalent on May 27, 2026, 159 days after the submission was received.
What is the product code of K254104?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.