Cleared Traditional

K190255 - Sensus Healthcare TVM Balloon Applicator

K190255 is the FDA 510(k) clearance for Sensus Healthcare TVM Balloon Applicator by Sensus Healthcare, Inc.. It is a Class 2 Radiology device (product code JAD) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K190255 · Sensus Healthcare, Inc. · Radiology device
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Feb 2019
Decision
14d
Days
Class 2
Risk

K190255 is an FDA 510(k) clearance for the Sensus Healthcare TVM Balloon Applicator. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Sensus Healthcare, Inc. (Boca Raton, US). The FDA issued a Cleared decision on February 21, 2019 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - the FDA radiology and imaging software 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sensus Healthcare, Inc. devices

Submission Details

510(k) Number K190255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2019
Decision Date February 21, 2019
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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 Radiology devices follow this clearance model.

Regulatory Peers - JAD System, Therapeutic, X-ray

All 13
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K190255.
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