Cleared Traditional

K801734 - IMED DROP RATE CALCULATOR #340

K801734 is the FDA 510(k) clearance for IMED DROP RATE CALCULATOR #340 by Imed Corp.. It is a Class 2 General Hospital device (product code FLN) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K801734 · Imed Corp. · General Hospital
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Oct 1980
Decision
90d
Days
Class 2
Risk

K801734 is an FDA 510(k) clearance for the IMED DROP RATE CALCULATOR #340. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Imed Corp. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2420 - 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 Imed Corp. devices

Submission Details

510(k) Number K801734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1980
Decision Date October 23, 1980
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLN Monitor, Electric For Gravity Flow Infusion Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2420
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 - FLN Monitor, Electric For Gravity Flow Infusion Systems

All 7
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K801734.
TRAVENOL FLO-GARD 500 IV MONITOR
K850710 · Travenol Laboratories, S.A. · Apr 1985
MODEL 460 INTERMITTENT MEDICATION DELIV
K823018 · Y · Jan 1983
MODEL AS* 7B AUTOSYRINGE INFUSION PUMP
K802166 · Baxter Healthcare Corp · Nov 1980
PARENTERAL INFUSION CONTROLLER
K780223 · Travenol Laboratories, S.A. · Apr 1978