Cleared Special

K120872 - ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS

K120872 is an FDA 510(k) clearance for ASANTE CONSET AND ASANTE COMFORT SUBCUT..., manufactured by Unomedical A/S Infusion Devices. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 29-day FDA review.

K120872 · Unomedical A/S Infusion Devices · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
29d
Days
Class 2
Risk

K120872 is an FDA 510(k) clearance for the ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASAN.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Unomedical A/S Infusion Devices (Osted, DK). The FDA issued a Cleared decision on April 20, 2012 after a review of 29 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.

FDA 510(k) Submission Details - K120872

510(k) Number K120872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2012
Decision Date April 20, 2012
Days to Decision 29 days
Submission Type Special
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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 966
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K120872.
NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE
K120443 · Baxter Healthcare Corporation - Renal Division · May 2012
HLIC NEEDLE-LESS VALVE
K120548 · Health Line International Corporation · May 2012
PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER
K120261 · Perouse Medical · May 2012
NEXUS TKO-6, LUER-ACTIVATED DEVICE
K113398 · Nexus Medical, LLC · Apr 2012
INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...
K112073 · Rx Devices, LLC · Apr 2012
ARISURE NEUTRAL VALVE
K120799 · Yukon Medical, LLC · Mar 2012
K120872 · ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
Download PDF FDA Summary Unomedical A/S Infusi…