Cleared Traditional

K924207 - AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET

K924207 is an FDA 510(k) clearance for AVI(TM) MODEL 232 STANDARD IV ADMINISTR..., manufactured by 3M Health Care, Ltd.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K924207 · 3M Health Care, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
279d
Days
Class 2
Risk

K924207 is an FDA 510(k) clearance for the AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 279 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 - K924207

510(k) Number K924207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1992
Decision Date May 26, 1993
Days to Decision 279 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 129d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 812
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K924207.
BAXTER SOLUTION ADMINISTRATION SETS
K924721 · Baxter Healthcare Corp · Jul 1993
SHROUDED NEEDLE DEVICES
K924718 · Imed Corp. · Jun 1993
INTERLINK(TM) INJECTION SITE
K925126 · Baxter Healthcare Corp · Jun 1993
INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET
K921899 · Baxter Healthcare Corp · Apr 1993
LIFESHIELD ANESTHESIA SET
K913982 · Abbott Laboratories · Nov 1992
INTERLINK(TM) INJECTION SITE
K922558 · Baxter Healthcare Corp · Oct 1992