Cleared Traditional

K052843 - BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE

K052843 is an FDA 510(k) clearance for BUSSE HOSPITAL DISPOSABLES NEEDLE STICK..., manufactured by Busse Hospital Disposables, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K052843 · Busse Hospital Disposables, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
192d
Days
Class 2
Risk

K052843 is an FDA 510(k) clearance for the BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Busse Hospital Disposables, Inc. (Hauppauge, US). The FDA issued a Cleared decision on April 17, 2006 after a review of 192 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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.

View all Busse Hospital Disposables, Inc. devices

FDA 510(k) Submission Details - K052843

510(k) Number K052843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2005
Decision Date April 17, 2006
Days to Decision 192 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
63d slower than avg
Panel avg: 129d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 465
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K052843.
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K052725 · Certol International, LLC · Dec 2005
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K053470 · Novo Nordisk, Inc. · Dec 2005