Cleared Traditional

K911400 - WALKAWAY TM 40

K911400 is an FDA 510(k) clearance for WALKAWAY TM 40, manufactured by Baxter Healthcare Corp. The device is a Class 2 Microbiology device with product code LRG cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K911400 · Baxter Healthcare Corp · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
235d
Days
Class 2
Risk

K911400 is an FDA 510(k) clearance for the WALKAWAY TM 40. Classified as Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (product code LRG), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (West Sacramento, US). The FDA issued a Cleared decision on November 19, 1991 after a review of 235 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K911400

510(k) Number K911400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1991
Decision Date November 19, 1991
Days to Decision 235 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 102d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRG Device Classification - Class 2, Special Controls

Product Code LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 Microbiology devices follow this clearance model.

Regulatory Peers - LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

All 41
Devices cleared under the same product code (LRG) and FDA review panel - the closest regulatory comparables to K911400.
SYNERGY SCREEN TEST, MODIFICATION
K921977 · Baxter Healthcare Corp · Oct 1993
READAR
K925951 · Alamar Biosciences Laboratory, Inc. · Aug 1993
MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL
K922482 · Baxter Diagnostics, Inc. · Mar 1993
AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING
K900821 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
AUTOSCEPTOR
K896447 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
SCEPTORPETTE SYSTEM
K883907 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988