Cleared Special

K060866 - PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS

K060866 is an FDA 510(k) clearance for PHASEAL - CLOSED SYSTEM FOR THE PREPARA..., manufactured by Carmel Pharma Ab.. The device is a Class 2 General Hospital device with product code LHI cleared through the Special 510(k) pathway after a 29-day FDA review.

K060866 · Carmel Pharma Ab. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
29d
Days
Class 2
Risk

K060866 is an FDA 510(k) clearance for the PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL .... Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Carmel Pharma Ab. (Gothenburg, SE). The FDA issued a Cleared decision on April 28, 2006 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 - K060866

510(k) Number K060866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2006
Decision Date April 28, 2006
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.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
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 - LHI Set, I.v. Fluid Transfer

All 189
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K060866.
VIAL2BAG
K072759 · Medimop Medical Projects, Ltd. · Dec 2007
TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K071741 · Migada Plant · Sep 2007
VENTED VIAL ADAPTER TRANSFER DEVICE
K062482 · Medimop Medical Projects, Ltd. · Nov 2006
SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD
K052790 · Cardinal Health, Alaris Products · Dec 2005
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K051669 · Migada Plant · Sep 2005
SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE
K050339 · Laboratorios Grifols, S.A. · Feb 2005
K060866 · PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS
Download PDF FDA Summary Carmel Pharma Ab.