Cleared Traditional

K923068 - AVI MODEL 3100 INFUSION PUMP

K923068 is an FDA 510(k) clearance for AVI MODEL 3100 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 299-day FDA review.

K923068 · 3M Health Care, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
299d
Days
Class 2
Risk

K923068 is an FDA 510(k) clearance for the AVI MODEL 3100 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 20, 1993 after a review of 299 days - an extended review 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: 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 3M Health Care, Ltd. devices

FDA 510(k) Submission Details - K923068

510(k) Number K923068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1992
Decision Date April 20, 1993
Days to Decision 299 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
170d slower than avg
Panel avg: 129d · This submission: 299d
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 611
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K923068.
MODEL 885 INFUSION PUMP, MODIFICATION
K924872 · 3M Health Care, Ltd. · Jun 1993
SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS
K923875 · I-Flow Corp. · May 1993
REPLACEMENT RECHARGEABLE BATTERY PACK'S
K925449 · Portable Power Systems, Inc. · Apr 1993
LIFECARE 175 INFUSER -- MODIFICATION
K923829 · Abbott Laboratories · Apr 1993
IVAC SYRINGE PUMP - 740 SERIES
K923981 · Y · Jan 1993
PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON
K923601 · Abbott Laboratories · Dec 1992