Cleared Traditional

K081449 - ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER

K081449 is an FDA 510(k) clearance for ULTIGUARD HOME INSULIN PEN NEEDLE DISPE..., 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 11-day FDA review.

K081449 · Ultimed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
11d
Days
Class 2
Risk

K081449 is an FDA 510(k) clearance for the ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Ultimed, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 3, 2008 after a review of 11 days - a notably fast clearance 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: 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 Ultimed, Inc. devices

FDA 510(k) Submission Details - K081449

510(k) Number K081449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2008
Decision Date June 03, 2008
Days to Decision 11 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 129d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K081449.
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