Cleared Traditional

K191614 - BioSticker System

K191614 is an FDA 510(k) clearance for BioSticker System, manufactured by Biointellisense, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K191614 · Biointellisense, Inc. · Cardiovascular device
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Dec 2019
Decision
183d
Days
Class 2
Risk

K191614 is an FDA 510(k) clearance for the BioSticker System. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Biointellisense, Inc. (Redwood City, US). The FDA issued a Cleared decision on December 18, 2019 after a review of 183 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biointellisense, Inc. devices

FDA 510(k) Submission Details - K191614

510(k) Number K191614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2019
Decision Date December 18, 2019
Days to Decision 183 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 125d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 73
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K191614.
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