Cleared Special

K090634 - PHASEAL PROTECTOR P14, P21, P28 AND P50

K090634 is an FDA 510(k) clearance for PHASEAL PROTECTOR P14, 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 14-day FDA review.

K090634 · Carmel Pharma Ab. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
14d
Days
Class 2
Risk

K090634 is an FDA 510(k) clearance for the PHASEAL PROTECTOR P14, P21, P28 AND P50. 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 March 23, 2009 after a review of 14 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 - K090634

510(k) Number K090634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2009
Decision Date March 23, 2009
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 K090634.
EQUALSHIELD LUER LOCK CONNECTOR PAIR
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INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022
K083851 · Inviro Medical Devices, Inc. · May 2009
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
K090905 · B.Braun Medical, Inc. · Apr 2009
EQUASHIELD SYSTEM
K083152 · Plastmed, Ltd. · Feb 2009
NEXUS I.V. FLUID TRANSFER DEVICE
K080976 · Nexus Medical, LLC · Nov 2008
QUICKPIN
K082752 · Laboratorios Grifols, S.A. · Sep 2008
K090634 · PHASEAL PROTECTOR P14, P21, P28 AND P50
Download PDF FDA Summary Carmel Pharma Ab.