Cleared Traditional

K831462 - API UNISCEPT PLUS 140 INOCULATOR

K831462 is an FDA 510(k) clearance for API UNISCEPT PLUS 140 INOCULATOR, manufactured by Analytical Products, Inc.. The device is a Class 1 Microbiology device with product code JTC cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K831462 · Analytical Products, Inc. · Microbiology device
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Aug 1983
Decision
98d
Days
Class 1
Risk

K831462 is an FDA 510(k) clearance for the API UNISCEPT PLUS 140 INOCULATOR. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Analytical Products, Inc. (Walker, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2500 - 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 Analytical Products, Inc. devices

FDA 510(k) Submission Details - K831462

510(k) Number K831462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1983
Decision Date August 12, 1983
Days to Decision 98 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
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

JTC Device Classification - Class 1, General Controls

Product Code JTC Device, Microtiter Diluting/dispensing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2500
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.

Regulatory Peers - JTC Device, Microtiter Diluting/dispensing

All 36
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K831462.
TITERTEK DULUTER/DISPENSER 78-640-00
K844568 · Flow Laboratories, Inc. · Jan 1985
TITERTEK MICROPLATE WASHER 120
K844500 · Flow Laboratories, Inc. · Jan 1985
T.I.M.E. DISPENSER
K843272 · Dynatech Laboratories, Inc. · Sep 1984
WASHER 6000 MICRO-C LISA SYSTEM
K831640 · Organon Teknika Corp. · Aug 1983
PIPETTE 12 CHANNEL
K831644 · Organon Teknika Corp. · Aug 1983
API UNISCEPT PLUS AUTOINOCULATOR
K831341 · Analytical Products, Inc. · Jun 1983