Cleared Traditional

K130524 - BREATHID HP SYSTEM

K130524 is the FDA 510(k) clearance for BREATHID HP SYSTEM by Exalenz Bioscience , Ltd.. It is a Class 1 Microbiology device (product code MSQ) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K130524 · Exalenz Bioscience , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
83d
Days
Class 1
Risk

K130524 is an FDA 510(k) clearance for the BREATHID HP SYSTEM. Classified as Test, Urea (breath Or Blood) (product code MSQ), Class I - General Controls.

Submitted by Exalenz Bioscience , Ltd. (Wheat Ridge, US). The FDA issued a Cleared decision on May 22, 2013 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - the FDA microbiology device 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 Exalenz Bioscience , Ltd. devices

Submission Details

510(k) Number K130524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2013
Decision Date May 22, 2013
Days to Decision 83 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 102d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSQ Test, Urea (breath Or Blood)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.