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)
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.

View all B.Braun Medical, Inc. devices

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 120
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K100640.
VIALOK NON-VENTED
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K092246 · Nipro Medical Corporation · Nov 2009
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