Cleared Traditional

K101309 - EXELINT ALUMINUM HUB BLUNT NEEDLES

K101309 is an FDA 510(k) clearance for EXELINT ALUMINUM HUB BLUNT NEEDLES, manufactured by Exelint International, Co.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K101309 · Exelint International, Co. · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K101309

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.

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 157
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K101309.
INFUSION ADAPTER C100
K110023 · Carmel Pharma Ab. · Apr 2011
FLEBOSET DOUBLE
K102590 · Laboratorios Grifols, S.A. · Jan 2011
EQUASHIELD SYSTEM PROTECTIVE PLUS
K101940 · Equashield Medical , Ltd. · Nov 2010
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
K100640 · B.Braun Medical, Inc. · Jul 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