510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K191614Substantially Equivalent

BioSticker System

Biointellisense Inc., Redwood City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K191614 is the FDA 510(k) clearance record for BioSticker System, a class II device, cleared for Biointellisense, Inc. on under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency). FDA records list 2 510(k) clearances for Biointellisense, Inc., from to . As of , FDA records show no recalls naming K191614.

Clearance record

Decision date
Received
(183 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
Biointellisense, Inc. 570 El Camino Real, Redwood City CA
510(k) summary
Statement
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