Cleared Traditional

MULTI-DRUG(TM) INFUSION SYSTEM (K892210) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K892210 · I-Flow Corp. · General Hospital
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Aug 1989
Decision
147d
Days
Class 2
Risk

K892210 is an FDA 510(k) clearance for the MULTI-DRUG(TM) 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 August 28, 1989 after a review of 147 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

Submission Details

510(k) Number K892210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1989
Decision Date August 28, 1989
Days to Decision 147 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
18d slower than avg
Panel avg: 129d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 236
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K892210.
MODEL 285 INFUSION PUMP
K894321 · 3M Company · Oct 1989
MODEL 480 INFUSION PUMP
K894320 · 3M Company · Oct 1989
MODEL 280 INFUSION PUMP
K894360 · 3M Company · Oct 1989
LIFECARE MICRO PUMP
K883645 · Abbott Laboratories · Aug 1989
60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE
K892906 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1989
BASAL/BOLUS INFUSORS
K884505 · Baxter Healthcare Corp · Jul 1989