Cleared Traditional

K874481 - IVAC VOLUMETRIC CONTROLLER - MODEL 290

K874481 is the FDA 510(k) clearance for IVAC VOLUMETRIC CONTROLLER - MODEL 290 by Y. It is a Class 2 General Hospital device (product code LDR) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K874481 · Y · General Hospital
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Mar 1988
Decision
122d
Days
Class 2
Risk

K874481 is an FDA 510(k) clearance for the IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on March 3, 1988 after a review of 122 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Y devices

Submission Details

510(k) Number K874481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1987
Decision Date March 03, 1988
Days to Decision 122 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 129d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 General Hospital devices follow this clearance model.

Regulatory Peers - LDR Controller, Infusion, Intravascular, Electronic

All 28
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K874481.
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+
K894487 · Y · Sep 1989
LIFECARE 75 CONTROLLER
K893487 · Abbott Laboratories · Jul 1989
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262
K884307 · Y · Nov 1988
TECHNICON CHEM 1(TM) SYSTEM
K874916 · Technicon Instruments Corp. · Mar 1988
IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+
K874491 · Y · Feb 1988
IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280
K870317 · Y · Apr 1987