Cleared Traditional

K021916 - HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001

K021916 is an FDA 510(k) clearance for HARMAC HUBER NEEDLE SAFETY DEVICE, manufactured by Harmac Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K021916 · Harmac Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
79d
Days
Class 2
Risk

K021916 is an FDA 510(k) clearance for the HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Harmac Medical Products, Inc. (Buffalo, US). The FDA issued a Cleared decision on August 29, 2002 after a review of 79 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 Harmac Medical Products, Inc. devices

FDA 510(k) Submission Details - K021916

510(k) Number K021916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2002
Decision Date August 29, 2002
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 129d · This submission: 79d
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 748
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K021916.
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K022209 · Alaris Medical Systems, Inc. · Aug 2002
SURECAN SAFETY HUBER NEEDLE INFUSION SETS
K021488 · B.Braun Medical, Inc. · Jul 2002
SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
K021530 · Sterling Medivations, Inc. · May 2002