FDA 510(k) · Spass
K230386: SpassageQ (Spass, Inc.)
Spass, Inc. received FDA 510(k) K230386 for SpassageQ, with a decision date of Jun 15, 2023 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K230386 |
|---|---|
| Pathway | 510(k) |
| Applicant | Spass, Inc. |
| Device name | SpassageQ |
| Product code | PLB: Multivariate Vital Signs Index |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Feb 14, 2023 |
| Decision date | Jun 15, 2023 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The SpassageQ is intended to be used with patient data from already cleared patient monitoring devices which measure respiratory rate, systolic blood pressure, and Glasgow Coma Scale (GCS) in patients being monitored in a healthcare facility. The device provides qSOFA score (also known as quickSOFA) which indicates patients with suspected infection who are at greater risk for a poor outcome. It uses three criteria, assigning one point for low blood pressure (SBP≤100 mmHg), high respiratory rate (≥22 breaths per min), or altered mentation (Glasgow coma scale<15). The SpassageQ is an adjunct to and is not intended to replace vital signs monitoring. The device is intended to provide additional information for use during patient monitoring in a healthcare facility. The device is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes. The device is intended for an adult population.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K230386
- K240558 NAVOYCDS (Algodx, Jul 22, 2024, PLB)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code PLB is "Multivariate Vital Signs Index", class 2, 21 CFR 870.2300. FDA's definition: "Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs."
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.