Cleared Traditional

K930406 - DURHAM

Also marketed or referenced as:
MIN BORE LUER LOCK EXTENSION SET

K930406 is an FDA 510(k) clearance for DURHAM, manufactured by Intl. Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K930406 · Intl. Medical, Inc. · General Hospital
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Sep 1993
Decision
220d
Days
Class 2
Risk

K930406 is an FDA 510(k) clearance for the DURHAM. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Intl. Medical, Inc. (Washington Crossing, US). The FDA issued a Cleared decision on September 3, 1993 after a review of 220 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 Intl. Medical, Inc. devices

FDA 510(k) Submission Details - K930406

510(k) Number K930406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date September 03, 1993
Days to Decision 220 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
91d slower than avg
Panel avg: 129d · This submission: 220d
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 644
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K930406.
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DURHAM
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K925362 · Baxter Healthcare Corp · Aug 1993
EXEL HUBER INFUSION SET ROTATING WING
K926119 · Exel Intl. · Aug 1993