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ResScan Essentials

by Resmed Corp

510(k) K254104

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK254104 Date27 May 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
BZD
Device class
Class II
Regulation
21 CFR Part 868.5905
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ResScan Essentials is a Ventilator, Non-Continuous (Respirator) designed for clinical analysis and patient data management. It provides high-resolution, breath-by-breath respiratory data visualization, enabling detailed monitoring of therapy metrics and patient trends. This software facilitates real-time assessment of ventilatory support, aiding clinicians in optimizing treatment parameters for improved patient outcomes.

ResScan Essentials is supplied as a PC-based software solution, intended for use in clinical settings such as hospitals and anesthesia departments. It is single-use per session (non-reusable) and does not require sterility as it operates digitally. The system supports multiple FEI numbers and registration numbers for compatibility with various ventilator models. Authorized under FDA 510K clearance (K254104), it adheres to regulatory standards for Class II medical devices (868.5905) and is intended for anesthesiology applications as per advisory committee classification.

Similar devices

Other devices filed under FDA product code BZD (Ventilator, Non-Continuous (Respirator)).

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