510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212957Substantially Equivalent

BioButton System

Biolntellisense, Inc., Redwood City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212957 is the FDA 510(k) clearance record for BioButton System, a class II device, cleared for Biolntellisense, Inc. on under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency). FDA records list one 510(k) clearance for Biolntellisense, Inc. As of , FDA records show one recall naming K212957.

Clearance record

Decision date
Received
(452 days to decision)
Product code
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Regulation
21 CFR 870.2910
Device class
Class II
Review panel
Cardiovascular
Applicant
Biolntellisense, Inc. 570 El Camino Real, Redwood City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRG

Trailing 12 months
2 clearances under product code DRG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260