Cleared Traditional

K874916 - TECHNICON CHEM 1(TM) SYSTEM

K874916 is an FDA 510(k) clearance for TECHNICON CHEM 1(TM) SYSTEM, manufactured by Technicon Instruments Corp.. The device is a Class 2 Chemistry device with product code LDR cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K874916 · Technicon Instruments Corp. · Chemistry device
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Mar 1988
Decision
91d
Days
Class 2
Risk

K874916 is an FDA 510(k) clearance for the TECHNICON CHEM 1(TM) SYSTEM. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on March 3, 1988 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5725 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K874916

510(k) Number K874916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1987
Decision Date March 03, 1988
Days to Decision 91 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
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDR Device Classification - Class 2, Special Controls

Product Code LDR Controller, Infusion, Intravascular, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 Chemistry devices follow this clearance model.

Regulatory Peers - LDR Controller, Infusion, Intravascular, Electronic

All 32
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K874916.
LIFECARE 75 CONTROLLER
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K884307 · Y · Nov 1988
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K874481 · Y · Mar 1988
IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+
K874491 · Y · Feb 1988
IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280
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IVAC FLOW CONTROL ADMINISTRATION SET
K870132 · Y · Feb 1987