Cleared Traditional

K771058 - EPTONE BACK-UP BROTH, VACUTAINER (FDA 510(k) Clearance)

Class I Microbiology device.

K771058 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1977
Decision
18d
Days
Class 1
Risk

K771058 is an FDA 510(k) clearance for the EPTONE BACK-UP BROTH, VACUTAINER. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on July 1, 1977 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K771058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1977
Decision Date July 01, 1977
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 102d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTW System, Transport, Aerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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.