Cleared Traditional

K932446 - INJECTION SITE

K932446 is an FDA 510(k) clearance for INJECTION SITE, 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 193-day FDA review.

K932446 · 3M Health Care, Ltd. · General Hospital
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Nov 1993
Decision
193d
Days
Class 2
Risk

K932446 is an FDA 510(k) clearance for the INJECTION SITE. 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 November 29, 1993 after a review of 193 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 - K932446

510(k) Number K932446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1993
Decision Date November 29, 1993
Days to Decision 193 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
64d slower than avg
Panel avg: 129d · This submission: 193d
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 811
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K932446.
SUBCUTANEOUS INFUSION SET
K932637 · Douglas Medical Products Corp. · Jan 1994
IN-LINE BURETTE SET
K931658 · Douglas Medical Products Corp. · Dec 1993
HUBER NEEDLE INFUSION SET
K932638 · Douglas Medical Products Corp. · Dec 1993
ENERGIZED CONTAINER SYSTEM
K925418 · Abbott Laboratories · Nov 1993
AVI MODEL 4225 VENTED PIGGYBACK IV ADMIN SET
K912069 · 3M Avi, Inc. · Oct 1993
IVAC NEEDLELESS INJECTION VALVE
K922115 · Y · Oct 1993