FDA 510(k) · BioIntelliSense
K241101: BioButton System (Biointellisense, Inc.)
Biointellisense, Inc. received FDA 510(k) K241101 for BioButton System, with a decision date of Sep 26, 2024 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K241101 |
|---|---|
| Pathway | 510(k) |
| Applicant | Biointellisense, Inc. |
| Device name | BioButton System |
| Product code | DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation (21 CFR) | 870.2910 |
| Device class | Class 2 |
| Date received | Apr 22, 2024 |
| Decision date | Sep 26, 2024 |
| 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 BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis. Data are securely transmitted via wireless connection from the device for storage, review, analysis, and display. The Device can include the ability to display date and notify healthcare professionals when physiological data fall outside clinician-specified parameters. The data from the device are intended as an aid to diagnosis, diseases management, and treatment. The device is intended for use on users who are 18 years of age or older. The device is not intended to output physiological measurements while the user undergoes significant motion or is active. The device is not intended for critical care.
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.
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 DRG is "Transmitters And Receivers, Physiological Signal, Radiofrequency", class 2, 21 CFR 870.2910.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.