Cleared Traditional

K790669 - DROP CONTROLLER

K790669 is an FDA 510(k) clearance for DROP CONTROLLER, manufactured by Imed Corp.. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K790669 · Imed Corp. · General Hospital
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May 1979
Decision
38d
Days
Class 2
Risk

K790669 is an FDA 510(k) clearance for the DROP CONTROLLER. 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 May 14, 1979 after a review of 38 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Imed Corp. devices

FDA 510(k) Submission Details - K790669

510(k) Number K790669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1979
Decision Date May 14, 1979
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLN Device Classification - Class 2, Special Controls

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 16
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K790669.
MODEL AS* 7B AUTOSYRINGE INFUSION PUMP
K802166 · Baxter Healthcare Corp · Nov 1980
INFUSSION ALARM SYSTEM I.A.S. CAT.#1118
K802011 · Pollak (Intl.), Ltd. · Oct 1980
IMED DROP RATE CALCULATOR #340
K801734 · Imed Corp. · Oct 1980
VOLUMETRIC CONTROLLER MODEL 310
K781589 · Imed Corp. · Nov 1978
PARENTERAL INFUSION CONTROLLER
K780223 · Travenol Laboratories, S.A. · Apr 1978
PARENTERAL INFUSION CONTROLLER, ELEC.
K780106 · National Patent Development Corp. · Feb 1978