Cleared Traditional

EXELINT ALUMINUM HUB BLUNT NEEDLES (K101309) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101309 · Exelint International, Co. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2010
Decision
163d
Days
Class 2
Risk

K101309 is an FDA 510(k) clearance for the EXELINT ALUMINUM HUB BLUNT NEEDLES. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Exelint International, Co. (Los Angeles, US). The FDA issued a Cleared decision on October 20, 2010 after a review of 163 days - an extended review cycle.

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 Exelint International, Co. devices

Submission Details

510(k) Number K101309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2010
Decision Date October 20, 2010
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 129d · This submission: 163d
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 64
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K101309.
Universal Spike
K150787 · B.Braun Medical, Inc. · Dec 2015
DUAL SPIKE TRANSFER DEVICE
K120150 · B.Braun Medical, Inc. · May 2012
MEDLINE VIAL DECANTER
K111577 · Medline Industries, Inc. · Sep 2011
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
K100640 · B.Braun Medical, Inc. · Jul 2010
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