Cleared Traditional

K071307 - INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003

K071307 is an FDA 510(k) clearance for INVIROLINK AND INVIRO TIP BLUNT CANNULAS, manufactured by Inviro Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K071307 · Inviro Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
279d
Days
Class 2
Risk

K071307 is an FDA 510(k) clearance for the INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 1400.... Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Inviro Medical Devices, Inc. (Duluth, US). The FDA issued a Cleared decision on February 12, 2008 after a review of 279 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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.

FDA 510(k) Submission Details - K071307

510(k) Number K071307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2007
Decision Date February 12, 2008
Days to Decision 279 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
150d slower than avg
Panel avg: 129d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 632
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K071307.
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K071307 · INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003
Download PDF FDA Summary Inviro Medical Device…