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SpassageQ

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230386

by Spass, Inc.

Identifiers

510(k) Number
K230386 FDA 510(k)
FDA Product Code
PLB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2300 FDA 510(k)
Regulation Number
870.2300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SpassageQ is a Multivariate Vital Signs Index device intended for use in cardiovascular applications. It is designed to process patient data from already cleared patient monitoring devices that measure respiratory rate, systolic blood pressure, and Glasgow Coma Scale (GCS).

The device provides a qSOFA score (quickSOFA) to help identify patients with suspected infection who are at greater risk for poor outcomes. It is used in healthcare facilities and was cleared via the FDA 510(k) pathway under K230386, with a traditional clearance decision and classification as a Class II device.

Frequently asked questions

What is the SpassageQ used for?

The SpassageQ is intended to process patient data from cleared monitoring devices measuring respiratory rate, systolic blood pressure, and Glasgow Coma Scale to provide a qSOFA score, which helps identify patients with suspected infection who are at greater risk for poor outcomes in cardiovascular applications.

How does the SpassageQ receive patient data?

The SpassageQ is designed to process data from already cleared patient monitoring devices that measure respiratory rate, systolic blood pressure, and Glasgow Coma Scale, meaning it does not directly measure these parameters but instead analyzes data imported from external monitors.

Is the SpassageQ a single-use or reusable device?

The device data does not specify whether the SpassageQ is single-use or reusable; however, as a software-based index that processes data from external monitors, it is likely intended for repeated use as a diagnostic tool rather than a consumable.

What regulatory pathway was used for the SpassageQ?

The SpassageQ was cleared via the FDA 510(k) pathway under submission number K230386, with a traditional clearance decision and classification as a Class II device, indicating it was found substantially equivalent to a legally marketed predicate.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K230386 - SpassageQ | FDA 510 (k) | Spass, Inc., SpassageQ (K230386) — FDA 510(k) | Innolitics, PDF K230386 - SpassageQ, 510(k) Premarket Notification - Food and Drug Administration, SpassageQ 510(k) K230386 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spass, Inc.

Sources (1)

  • FDA 510(k) K230386 24 fields · synced Sep 21, 2026