Cleared Traditional

K100640 - 20 MMVIAL FLUID TRANSFER ADAPTER

K100640 is the FDA 510(k) clearance for 20 MMVIAL FLUID TRANSFER ADAPTER by B.Braun Medical, Inc.. It is a Class 2 General Hospital device (product code LHI) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K100640 · B.Braun Medical, Inc. · General Hospital
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Jul 2010
Decision
139d
Days
Class 2
Risk

K100640 is an FDA 510(k) clearance for the 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500. 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 July 22, 2010 after a review of 139 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

Submission Details

510(k) Number K100640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2010
Decision Date July 22, 2010
Days to Decision 139 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
10d slower than avg
Panel avg: 129d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 69
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K100640.
ADD-VANTAGE ADDAPTOR
K133602 · Hospira, Inc. · Jan 2014
DUAL SPIKE TRANSFER DEVICE
K120150 · B.Braun Medical, Inc. · May 2012
MEDLINE VIAL DECANTER
K111577 · Medline Industries, Inc. · Sep 2011
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
K092318 · Baxter Healthcare Corporation · Oct 2009
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
K090905 · B.Braun Medical, Inc. · Apr 2009
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
K041222 · B.Braun Medical, Inc. · Oct 2004