FDA 510(k) · Biofourmis
K183282: Biovitals Analytics Engine (Biofourmis Singapore Pte., Ltd.)
Biofourmis Singapore Pte., Ltd. received FDA 510(k) K183282 for Biovitals Analytics Engine, with a decision date of Aug 15, 2019 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K183282 |
|---|---|
| Pathway | 510(k) |
| Applicant | Biofourmis Singapore Pte., Ltd. |
| Device name | Biovitals Analytics Engine |
| Product code | PLB: Multivariate Vital Signs Index |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Nov 26, 2018 |
| Decision date | Aug 15, 2019 |
| 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 Biovitals Analytic Engine (BA Engine) is intended to be used with continuous biometric data from already cleared sensors measuring heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. The device learns the correlation between multiple vital signs during the patient’s daily activity and builds an individualized biometric signature which is dynamically updated based on incoming data. The device computes a time series Biovitals Index (BI), which reflects changes in the patient’s measured vital signs from their measured baseline, which is derived from the individualized biometric signature of the patient. The BA Engine is a cloud-based software engine, intended to be an adjunct to and is not intended to replace vital signs monitoring. The BI is intended for daily intermittent, retrospective review by a qualified practitioner. The BA Engine is intended to provide additional information for use during routine patient monitoring. The BI is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes. The device is intended for an adult population. Summary
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.
- K142512 Personalized Physiology Analytics Engin… (VGBio (dba physIQ))
Later records that cite K183282
- K230386 SpassageQ (Spass, Jun 15, 2023, 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.