Cleared Traditional

K812340 - TITERTEK MICROPLATE INCUBATOR

K812340 is an FDA 510(k) clearance for TITERTEK MICROPLATE INCUBATOR, manufactured by Flow Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JTQ cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K812340 · Flow Laboratories, Inc. · Chemistry device

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Sep 1981

Decision

36d

Days

Class 1

Risk

K812340 is an FDA 510(k) clearance for the TITERTEK MICROPLATE INCUBATOR. Classified as Bath, Incubators/water, All (product code JTQ), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2540 - the FDA in vitro diagnostics and chemistry 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.

FDA 510(k) Submission Details - K812340

510(k) Number	K812340 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 1981
Decision Date	September 23, 1981
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

53d faster than avg

Panel avg: 89d · This submission: 36d

Pathway characteristics

Predicate-based equivalence.

JTQ Device Classification - Class 1, General Controls

Product Code	JTQ Bath, Incubators/water, All
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 866.2540

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 - JTQ Bath, Incubators/water, All

All 11

Devices cleared under the same product code (JTQ) and FDA review panel - the closest regulatory comparables to K812340.

LBI-100 37DEGREES INCUBATOR

K830405 · Bionetic Laboratory Products · Mar 1983

WATER BATH

K822564 · Boekel Industries, Inc. · Sep 1982

FORMA CH/P GAS PROCESSOR

K812826 · Forma Scientific, Inc. · Oct 1981

SPOR-O-THERM

K801462 · Mdt Corp., Inc. · Jul 1980

TEMPTRONIC 100 WATER BATH

K792060 · Sybron Corp. · Dec 1979

BLOOD BANK DRI-BATH

K760928 · Thermolyne Corp. · Jan 1977

FDA 510(k) Resources - Chemistry

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K812340

Flow Laboratories, Inc.

Mchenry, IL · US

Regulatory profile

57 submissions 56 cleared

98% clearance rate · Active in Chemistry

View all devices by Flow Laboratories, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: September 23, 1981. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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510k Database

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