Cleared Special

K091389 - EQUALSHIELD LUER LOCK CONNECTOR PAIR

K091389 is an FDA 510(k) clearance for EQUALSHIELD LUER LOCK CONNECTOR PAIR, manufactured by Plastmed, Ltd.. The device is a Class 2 General Hospital device with product code LHI cleared through the Special 510(k) pathway after a 164-day FDA review.

K091389 · Plastmed, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
164d
Days
Class 2
Risk

K091389 is an FDA 510(k) clearance for the EQUALSHIELD LUER LOCK CONNECTOR PAIR. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Plastmed, Ltd. (Tefen Industrial Park, IL). The FDA issued a Cleared decision on October 22, 2009 after a review of 164 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K091389

510(k) Number K091389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2009
Decision Date October 22, 2009
Days to Decision 164 days
Submission Type Special
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
35d slower than avg
Panel avg: 129d · This submission: 164d
Pathway characteristics
Modification to existing cleared device.

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 189
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K091389.
INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,
K092782 · Carmel Pharma Ab. · Dec 2009
NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505
K092246 · Nipro Medical Corporation · Nov 2009
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
K092318 · Baxter Healthcare Corporation · Oct 2009
INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022
K083851 · Inviro Medical Devices, Inc. · May 2009
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
K090905 · B.Braun Medical, Inc. · Apr 2009
PHASEAL PROTECTOR P14, P21, P28 AND P50
K090634 · Carmel Pharma Ab. · Mar 2009
K091389 · EQUALSHIELD LUER LOCK CONNECTOR PAIR
Download PDF FDA Summary Plastmed, Ltd.