Cleared Abbreviated

K080695 - MOBILE I.V. SYSTEMS 10,20,60

K080695 is an FDA 510(k) clearance for MOBILE I.V. SYSTEMS 10, manufactured by Northwind Technologies, Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Abbreviated 510(k) pathway after a 112-day FDA review.

K080695 · Northwind Technologies, Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
112d
Days
Class 2
Risk

K080695 is an FDA 510(k) clearance for the MOBILE I.V. SYSTEMS 10,20,60. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Northwind Technologies, Corp. (Manchester, US). The FDA issued a Cleared decision on July 1, 2008 after a review of 112 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K080695

510(k) Number K080695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2008
Decision Date July 01, 2008
Days to Decision 112 days
Submission Type Abbreviated
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
17d faster than avg
Panel avg: 129d · This submission: 112d
Pathway characteristics
Standards-based clearance path.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 1024
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K080695 · MOBILE I.V. SYSTEMS 10,20,60
Download PDF FDA Summary Northwind Technologie…