Cleared Special

K083851 - INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022

K083851 is an FDA 510(k) clearance for INVIROBLUNT CANNULA WITH AND WITHOUT EZ..., manufactured by Inviro Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Special 510(k) pathway after a 142-day FDA review.

K083851 · Inviro Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
142d
Days
Class 2
Risk

K083851 is an FDA 510(k) clearance for the INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Inviro Medical Devices, Inc. (Lawrenceville, US). The FDA issued a Cleared decision on May 15, 2009 after a review of 142 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. 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 - K083851

510(k) Number K083851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2008
Decision Date May 15, 2009
Days to Decision 142 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
13d slower than avg
Panel avg: 129d · This submission: 142d
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 K083851.
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
EQUALSHIELD LUER LOCK CONNECTOR PAIR
K091389 · Plastmed, Ltd. · Oct 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
EQUASHIELD SYSTEM
K083152 · Plastmed, Ltd. · Feb 2009
K083851 · INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022
Download PDF FDA Summary Inviro Medical Device…