Cleared Traditional

K904619 - INFU.DISK

K904619 is an FDA 510(k) clearance for INFU.DISK, manufactured by Electrochemical Drug Delivery, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 390-day FDA review.

K904619 · Electrochemical Drug Delivery, Inc. · General Hospital
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Nov 1991
Decision
390d
Days
Class 2
Risk

K904619 is an FDA 510(k) clearance for the INFU.DISK. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Electrochemical Drug Delivery, Inc. (San Diego, US). The FDA issued a Cleared decision on November 5, 1991 after a review of 390 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Electrochemical Drug Delivery, Inc. devices

FDA 510(k) Submission Details - K904619

510(k) Number K904619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date November 05, 1991
Days to Decision 390 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
261d slower than avg
Panel avg: 129d · This submission: 390d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
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 - FRN Pump, Infusion

All 615
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K904619.
PROVIDER APM INFUSION PUMP
K914349 · Abbott Laboratories · Dec 1991
VIVUS PS (PROGRAMMING SOFTWARE)
K913907 · I-Flow Corp. · Dec 1991
PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM
K911782 · Strato Medical Corp. · Nov 1991
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
K913718 · Abbott Laboratories · Oct 1991
PANCRETEC I.V. MODEL 5500 INFUSER
K913719 · Abbott Laboratories · Oct 1991
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
K913720 · Abbott Laboratories · Oct 1991