Cleared Special

K023747 - PHASEAL

K023747 is an FDA 510(k) clearance for PHASEAL, 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 7-day FDA review.

K023747 · Carmel Pharma Ab. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
7d
Days
Class 2
Risk

K023747 is an FDA 510(k) clearance for the PHASEAL. 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 November 15, 2002 after a review of 7 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 - K023747

510(k) Number K023747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2002
Decision Date November 15, 2002
Days to Decision 7 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
122d faster than avg
Panel avg: 129d · This submission: 7d
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 K023747.
MIX2VIAL TRANSFER DEVICE
K031861 · Medimop Medical Projects, Ltd. · Jul 2003
CHEMO DISPENSING PIN, MODEL 12495
K024239 · Abbott Laboratories · Jan 2003
STERI-SPOUTS
K023539 · Valumed · Dec 2002
RAPID-FILL TUBESET, MODEL 90005
K022523 · Baxa Corp. · Aug 2002
ANGELTOUCH VENTED IV ADMINISTRATION SET
K012189 · Angiplast Private , Ltd. · Mar 2002
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
K013523 · Shire Biologics, Inc. · Jan 2002
K023747 · PHASEAL
Download PDF FDA Summary Carmel Pharma Ab.