Cleared Special

K111016 - SAFEPORT MANIFOLD (TM) (OR STOPCOCK)

K111016 is an FDA 510(k) clearance for SAFEPORT MANIFOLD (TM) (OR STOPCOCK), manufactured by Elcam Medical Acal. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 58-day FDA review.

K111016 · Elcam Medical Acal · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
58d
Days
Class 2
Risk

K111016 is an FDA 510(k) clearance for the SAFEPORT MANIFOLD (TM) (OR STOPCOCK). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Elcam Medical Acal (Mp. Merom Hagalil, IL). The FDA issued a Cleared decision on June 9, 2011 after a review of 58 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 Elcam Medical Acal devices

FDA 510(k) Submission Details - K111016

510(k) Number K111016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2011
Decision Date June 09, 2011
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
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 534
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K111016.
CYTOGUARD(TM) CLOSED LUER CONNECTOR
K112636 · B.Braun Medical, Inc. · Nov 2011
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS
K112893 · Baxter Healthcare Corporation · Oct 2011
INFUSION SET FOR POWERPICC SOLO 2 CATHETER
K102405 · C.R. Bard, Inc. · Jul 2011
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,
K103551 · Baxter Healthcare Corp · Mar 2011
HOSPIRA PLUM INFUSION SET
K103224 · Hospira, Inc. · Jan 2011
HIGH PRESSURE SETS-400 PSI
K100576 · Icu Medical, Inc. · Dec 2010