Data / Medical devices / United States / Biointellisense Inc.

Biointellisense Inc.: FDA-registered device maker in Redwood City, CA, United States, 3 510(k) clearances

Name: Biointellisense Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Biointellisense Inc. is registered with the FDA (registration 3016592682) in Redwood City, CA, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 26, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016592682
Address: 805 Veterans Blvd UNIT 105, Redwood City, CA, United States, 94063
Owner or operator: BioIntelliSense Inc. (10062701)
Roles: Manufacturer, Specification developer
First device listed: March 3, 2020
Registered through: 2026
Brand names listed: BioButton Adhesive V2, Cold Seal (ADH-CS), BioButton Adhesives v1 (2x5pcs and 50x5pcs, OMI, ADB, ACCS-1-ST06-1-4F), BioButton Adhesives v2 (2x5pcs and 50x5pcs, HT, ADD, ADH-AC1-BBR), BioButton Charging Station, BioButton MPU, BioButton Rechargeable, BioButton Rechargeable (BBR), BioButton System (Multi-patient Use or MPU) and more

Devices it lists

Device	Product code	Class	Role	Source
Calculator, Drug Dose	NDC	2	Specification developer	accessdata.fda.gov
Monitor, Bed Patient	KMI	1	Manufacturer	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Manufacturer, Specification developer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Specification developer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 26, 2024	K241101	BioButton System	DRG	Substantially Equivalent	Biointellisense, Inc.	accessdata.fda.gov
December 12, 2022	K212957	BioButton System	DRG	Substantially Equivalent	Biolntellisense, Inc.	accessdata.fda.gov
December 18, 2019	K191614	BioSticker System	DRG	Substantially Equivalent	Biointellisense, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 19, 2024	94943	Class II	Ongoing	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	Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.	accessdata.fda.gov

Compare with other makers

Updated September 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.