Cleared Traditional

K901978 - MULTI-DRUG INFUSION SYSTEM

K901978 is an FDA 510(k) clearance for MULTI-DRUG INFUSION SYSTEM, manufactured by I-Flow Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K901978 · I-Flow Corp. · General Hospital
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Sep 1990
Decision
149d
Days
Class 2
Risk

K901978 is an FDA 510(k) clearance for the MULTI-DRUG INFUSION SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by I-Flow Corp. (Irvine, US). The FDA issued a Cleared decision on September 28, 1990 after a review of 149 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 I-Flow Corp. devices

FDA 510(k) Submission Details - K901978

510(k) Number K901978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1990
Decision Date September 28, 1990
Days to Decision 149 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
20d slower than avg
Panel avg: 129d · This submission: 149d
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 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K901978.
IVAC(R) SYRINGE PUMP - MODEL 770
K901550 · Y · Oct 1990
IVAC(R) SYRINGE PUMP - MODEL 740
K903879 · Y · Oct 1990
MULTI DRUG INFUSION SYSTEM
K904048 · I-Flow Corp. · Oct 1990
AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
K902432 · Abbott Laboratories · Sep 1990
CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM
K902374 · Pharmacia Deltec, Inc. · Sep 1990
LIFECARE MODEL 4 PUMP
K900467 · Abbott Laboratories · Aug 1990