Cleared Traditional

K083765 - MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FPA Set, Administration, Intravascular

All 879
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K083765.
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K082027 · Genesis Bps, LLC · Feb 2009
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MISER CONTRAST MANAGEMENT SYSTEM
K083576 · Merit Medical Systems, Inc. · Dec 2008
MEDEGEN PRESSURE RATED EXTENSION SETS
K083472 · Medegen, Inc. · Dec 2008

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.