Cleared Traditional

K140175 - INTRAVASCULAR ADMINISTRATION SET

K140175 is an FDA 510(k) clearance for INTRAVASCULAR ADMINISTRATION SET, manufactured by Delta Med Spa. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K140175 · Delta Med Spa · General Hospital
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Aug 2014
Decision
194d
Days
Class 2
Risk

K140175 is an FDA 510(k) clearance for the INTRAVASCULAR ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Delta Med Spa (Rome, IT). The FDA issued a Cleared decision on August 5, 2014 after a review of 194 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 Delta Med Spa devices

FDA 510(k) Submission Details - K140175

510(k) Number K140175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2014
Decision Date August 05, 2014
Days to Decision 194 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
65d slower than avg
Panel avg: 129d · This submission: 194d
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 783
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K140175.
SELEC-3 I.V.ADMINISTRATION SET
K142097 · Biomedix, Inc. · Aug 2014
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
K142036 · B.Braun Medical, Inc. · Aug 2014
SOLUTION SET/EXTENSION SET
K142011 · Baxter Healthcare Corporation · Aug 2014
SAPPHIRE ADMINISTRATION SET
K141834 · Q Core Medical , Ltd. · Aug 2014
TEVADAPTOR
K141306 · Teva Medical Ltd., Migada Plant · Jun 2014
NEXUS NIS-6P LUER ACTIVATED DEVICE
K133351 · Nexus Medical, LLC · May 2014