ResScan Essentials— 510(k) K254104
Substantially EquivalentResmed Corp
FDA 510(k) clearance K254104 for ResScan Essentials, Substantially Equivalent on 2026-05-27. Applicant: Resmed Corp. Device class: 2.
Summary
ResScan Essentials comes from Resmed Corp and is filed under BZD, non-continuous ventilators (respirators). The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 868.5905. Anesthesiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Resmed filed from San Diego, California. Review took 159 calendar days (December 19, 2025 to May 27, 2026).
Clearance details
- Applicant
- Resmed Corp
- Product code
- Product code BZD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code BZD
view allMore clearances from Resmed Corp
view allAdverse events under product code BZD
product code BZD- Death
- 4,440
- Injury
- 53,099
- Malfunction
- 213,222
- Other
- 17
- Total
- 270,778
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.