Cleared Traditional

K083765 - MAXGUARD ADVANCED LUER ACTIVATED DEVICE...

K083765 is an FDA 510(k) clearance for MAXGUARD ADVANCED LUER ACTIVATED DEVICE..., manufactured by Medegen Medical Manufacturing Services. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K083765 · Medegen Medical Manufacturing Services · General Hospital
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Dec 2008
Decision
12d
Days
Class 2
Risk

K083765 is an FDA 510(k) clearance for the MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Medegen Medical Manufacturing Services (Ontario, US). The FDA issued a Cleared decision on December 30, 2008 after a review of 12 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medegen Medical Manufacturing Services devices

FDA 510(k) Submission Details - K083765

510(k) Number K083765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2008
Decision Date December 30, 2008
Days to Decision 12 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 129d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 534
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