BioButton System— 510(k) K212957

Name: FDA 510(k) clearance K212957
Creator: U.S. Food and Drug Administration
Published: 2022-12-12

Substantially Equivalent

Biolntellisense, Inc.

FDA 510(k) clearance K212957 for BioButton System, Substantially Equivalent on 2022-12-12. Applicant: Biolntellisense, Inc.. Device class: 2.

Clearance details

Applicant: Biolntellisense, Inc.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2021-09-16
Decision date: 2022-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K212957

K-number listed on FDA's recall record

Z-2616-2024 — BioButton REF BIOST06040 with Software version 3.0.20 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.Class II·Ongoing·Biointellisense Inc.·20240719

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212957.

Data sourced from openFDA. This site is unofficial and independent of the FDA.