Cleared Special

SUB-Q SUBCUTANEOUS TISSUE INFUSION SET (K140131) - FDA 510(k) Clearance

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

K140131 · Emed Technologies Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
76d
Days
Class 2
Risk

K140131 is an FDA 510(k) clearance for the SUB-Q SUBCUTANEOUS TISSUE INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Emed Technologies Corporation (El Dorado Hills, US). The FDA issued a Cleared decision on April 3, 2014 after a review of 76 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 Emed Technologies Corporation devices

Submission Details

510(k) Number K140131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2014
Decision Date April 03, 2014
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
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 238
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K140131.
IV ADMINISTRATION SET WITH HAND PUMP
K140838 · B.Braun Medical, Inc. · Dec 2014
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
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
K123874 · Baxter Healthcare Corp · Jan 2013
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
K123868 · Baxter Healthcare Corp · Jan 2013