Cleared Traditional

K963830 - SHARPS CONTAINER MODEL# SC001

K963830 is an FDA 510(k) clearance for SHARPS CONTAINER MODEL# SC001, manufactured by Image Medical, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K963830 · Image Medical, Inc. · General Hospital
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Feb 1997
Decision
139d
Days
Class 2
Risk

K963830 is an FDA 510(k) clearance for the SHARPS CONTAINER MODEL# SC001. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Image Medical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 139 days - within the typical 510(k) review window.

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 Image Medical, Inc. devices

FDA 510(k) Submission Details - K963830

510(k) Number K963830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1996
Decision Date February 10, 1997
Days to Decision 139 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
10d slower than avg
Panel avg: 129d · This submission: 139d
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 455
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K963830.
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K963595 · Cutting Edge Technologies, Inc. · Jan 1997
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K960982 · Sherwood Medical Co. · Dec 1996