Cleared Traditional

K870719 - SENSIR SYSTEM

K870719 is an FDA 510(k) clearance for SENSIR SYSTEM, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K870719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Jun 1987
Decision
115d
Days
Class 2
Risk

K870719 is an FDA 510(k) clearance for the SENSIR SYSTEM. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 15, 1987 after a review of 115 days - within the typical 510(k) review window.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K870719

510(k) Number K870719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1987
Decision Date June 15, 1987
Days to Decision 115 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
13d slower than avg
Panel avg: 102d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

Product Code JWY Manual Antimicrobial Susceptibility Test 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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 410
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K870719.
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL
K874876 · Baxter Healthcare Corp · Jan 1988
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
K874466 · Analytical Products, Inc. · Dec 1987
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO
K874426 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1987
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC
K870663 · Analytical Products, Inc. · Mar 1987
API UNISCEPT (TM) KB
K864891 · Analytical Products, Inc. · Feb 1987
MICRODILUTION MIC PANELS
K863776 · American Micro Scan · Feb 1987