Cleared Traditional

K920225 - AUTOSCEPTOR IDENTIFICATION SYSTEM

K920225 is an FDA 510(k) clearance for AUTOSCEPTOR IDENTIFICATION SYSTEM, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Microbiology device with product code LRH cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K920225 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Optimized for regulatory review, auditing and printing
May 1992
Decision
126d
Days
Class 1
Risk

K920225 is an FDA 510(k) clearance for the AUTOSCEPTOR IDENTIFICATION SYSTEM. Classified as Instrument For Auto Reader Of Overnight Microorganism Identification System (product code LRH), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 22, 1992 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K920225

510(k) Number K920225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1992
Decision Date May 22, 1992
Days to Decision 126 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 102d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

LRH Device Classification - Class 1, General Controls

Product Code LRH Instrument For Auto Reader Of Overnight Microorganism Identification System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.