Cleared Traditional

K920588 - AVI MODEL 3000 INFUSION PUMP

K920588 is an FDA 510(k) clearance for AVI MODEL 3000 INFUSION PUMP, manufactured by 3M Health Care, Ltd.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K920588 · 3M Health Care, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
56d
Days
Class 2
Risk

K920588 is an FDA 510(k) clearance for the AVI MODEL 3000 INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on April 6, 1992 after a review of 56 days - a notably fast clearance cycle.

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: 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 3M Health Care, Ltd. devices

FDA 510(k) Submission Details - K920588

510(k) Number K920588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1992
Decision Date April 06, 1992
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
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 454
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K920588.
AVI MODEL 470CI INFUSION PUMP
K921072 · 3M Health Care, Ltd. · May 1992
AVI MODEL 480CI INFUSION PUMP
K921073 · 3M Health Care, Ltd. · May 1992
DURAFUSE INFUSION PUMP
K920773 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1992
AVI MODEL 275CI INFUSION PUMP
K920680 · 3M Health Care, Ltd. · Apr 1992
AVI MODEL 285CI INFUSION PUMP
K920681 · 3M Health Care, Ltd. · Apr 1992
FLO-GARD 8000 HALF-SET
K915499 · Baxter Healthcare Corp · Mar 1992