Cleared Traditional

K930410 - DURHAM

Also marketed or referenced as:
LUER LOCK EXTENSION SET

K930410 is the FDA 510(k) clearance for DURHAM by Intl. Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K930410 · Intl. Medical, Inc. · General Hospital
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Sep 1993
Decision
220d
Days
Class 2
Risk

K930410 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

Submission Details

510(k) Number K930410 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
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.

Device Classification

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 279
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K930410.
EZ ADMINISTRATION SET
K931550 · Y · Jan 1994
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K925418 · Abbott Laboratories · Nov 1993
IVAC NEEDLELESS INJECTION VALVE
K922115 · Y · Oct 1993
SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
K925362 · Baxter Healthcare Corp · Aug 1993
BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET
K925058 · C.R. Bard, Inc. · Aug 1993
IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL
K925228 · Y · Jul 1993