Cleared Special

SELEC-3 I.V.ADMINISTRATION SET (K142097) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K142097 · Biomedix, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
28d
Days
Class 2
Risk

K142097 is an FDA 510(k) clearance for the SELEC-3 I.V.ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Biomedix, Inc. (Blmgtn, US). The FDA issued a Cleared decision on August 29, 2014 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomedix, Inc. devices

Submission Details

510(k) Number K142097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2014
Decision Date August 29, 2014
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 226
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K142097.
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INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
K142036 · B.Braun Medical, Inc. · Aug 2014
CARESITE LUER ACCESS DEVICE
K140311 · B.Braun Medical, Inc. · May 2014
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
K132734 · Baxter Healthcare Corp · Oct 2013