Cleared Traditional

K021983 - ULTI GUARD HOME INSULIN SYRINGE CONTAINER

K021983 is an FDA 510(k) clearance for ULTI GUARD HOME INSULIN SYRINGE CONTAINER, manufactured by Ultimed, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K021983 · Ultimed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
90d
Days
Class 2
Risk

K021983 is an FDA 510(k) clearance for the ULTI GUARD HOME INSULIN SYRINGE CONTAINER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Ultimed, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 16, 2002 after a review of 90 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 Ultimed, Inc. devices

FDA 510(k) Submission Details - K021983

510(k) Number K021983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2002
Decision Date September 16, 2002
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMK Device Classification - Class 2, Special Controls

Product Code MMK Container, Sharps
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 - MMK Container, Sharps

All 46
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K021983.
MEDLINE SHARPS CONTAINERS
K143693 · Medline Industries, Inc. · Nov 2015
MEDLINE SHARPS CONTAINER
K132767 · Medline Industries, Inc. · Feb 2014
BD RECYKLEEN SHARPS COLLECTORS
K112774 · Becton, Dickinson and Company · Mar 2012
SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
K980490 · Sage Products, Inc. · Feb 1998
POINT OF USE II SHARPS-A-GATOR
K964387 · Graphic Controls Corp. · Mar 1997
BEMIS TWO GALLON CHEMOTHERAPY CONTAINER
K964858 · Bemis Mfg. Co. · Feb 1997