Cleared Traditional

K080174 - PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C

K080174 is an FDA 510(k) clearance for PHLEBOTOMY BAG WITH VALVE & 17G X 1, manufactured by Cardio Med Supplies, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K080174 · Cardio Med Supplies, Inc. · General Hospital
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Apr 2008
Decision
90d
Days
Class 2
Risk

K080174 is an FDA 510(k) clearance for the PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Cardio Med Supplies, Inc. (Lindsay-Ontario, CA). The FDA issued a Cleared decision on April 23, 2008 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardio Med Supplies, Inc. devices

FDA 510(k) Submission Details - K080174

510(k) Number K080174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2008
Decision Date April 23, 2008
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 141
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K080174.
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
SMART-ROD
K070584 · Duoject Medical Systems, Inc. · Apr 2008
SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM
K072511 · Medimop Medical Projects, Ltd. · Dec 2007
VIAL2BAG
K072759 · Medimop Medical Projects, Ltd. · Dec 2007