Cleared Traditional

K120150 - DUAL SPIKE TRANSFER DEVICE

K120150 is an FDA 510(k) clearance for DUAL SPIKE TRANSFER DEVICE, manufactured by B.Braun Medical, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K120150 · B.Braun Medical, Inc. · General Hospital
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May 2012
Decision
127d
Days
Class 2
Risk

K120150 is an FDA 510(k) clearance for the DUAL SPIKE TRANSFER DEVICE. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on May 24, 2012 after a review of 127 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 B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K120150

510(k) Number K120150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2012
Decision Date May 24, 2012
Days to Decision 127 days
Submission Type Traditional
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
2d faster than avg
Panel avg: 129d · This submission: 127d
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 108
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K120150.
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VIALOK NON-VENTED
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MEDLINE VIAL DECANTER
K111577 · Medline Industries, Inc. · Sep 2011
INFUSION ADAPTER C100
K110023 · Carmel Pharma Ab. · Apr 2011