Cleared Special

K040527 - LOW PROFILE LUTHER SAFETY HUBER

K040527 is an FDA 510(k) clearance for LOW PROFILE LUTHER SAFETY HUBER, manufactured by Luther Needlesafe Products, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 25-day FDA review.

K040527 · Luther Needlesafe Products, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
25d
Days
Class 2
Risk

K040527 is an FDA 510(k) clearance for the LOW PROFILE LUTHER SAFETY HUBER. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Luther Needlesafe Products, Inc. (Irvine, US). The FDA issued a Cleared decision on March 26, 2004 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040527

510(k) Number K040527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2004
Decision Date March 26, 2004
Days to Decision 25 days
Submission Type Special
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
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 951
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K040527.
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K033892 · Disetronic Medical Systems AG · Mar 2004
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K033301 · Codan US Corp. · Mar 2004
K040527 · LOW PROFILE LUTHER SAFETY HUBER
Download PDF FDA Summary Luther Needlesafe Pro…