Cleared Traditional

K082027 - FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160

K082027 is an FDA 510(k) clearance for FLU-ADMIN, manufactured by Genesis Bps, LLC. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K082027 · Genesis Bps, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
211d
Days
Class 2
Risk

K082027 is an FDA 510(k) clearance for the FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Genesis Bps, LLC (Hackensack, US). The FDA issued a Cleared decision on February 13, 2009 after a review of 211 days - an extended review 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: 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 - K082027

510(k) Number K082027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2008
Decision Date February 13, 2009
Days to Decision 211 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
82d slower than avg
Panel avg: 129d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1127
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K082027.
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
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SUBCUTANEOUS NEEDLE INFUSION SET
K082818 · Marcal Medical, Inc. · Dec 2008
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K083576 · Merit Medical Systems, Inc. · Dec 2008
K082027 · FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160
Download PDF FDA Summary Genesis Bps, LLC