Cleared Traditional

K100640 - 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500

K100640 is an FDA 510(k) clearance for 20 MMVIAL FLUID TRANSFER ADAPTER, 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 139-day FDA review.

K100640 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K100640

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.

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 206
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K100640.
FLEBOSET DOUBLE
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EXELINT ALUMINUM HUB BLUNT NEEDLES
K101309 · Exelint International, Co. · Oct 2010
SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K090917 · Baxa Corp. · Feb 2010
SET GRI-FILL 3.0
K093182 · Laboratorios Grifols, S.A. · Jan 2010
INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,
K092782 · Carmel Pharma Ab. · Dec 2009
K100640 · 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
Download PDF FDA Summary B.Braun Medical, Inc.