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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MMK Container, Sharps

All 104
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K081449.
GONGDONG DISPOSABLE SHARP CONTAINER
K082042 · Zhejiang Gongdong Medical Plastic Factory · Sep 2008
D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)
K081821 · Global Pathogen Solutions, Inc. · Sep 2008
SHARPS TRANSPORT TUBE, MODEL 50035
K073577 · Sharps Compliance, Inc. · Jun 2008
AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.
K071517 · A.B.M. Italia S.P.A · Apr 2008
SHARPS AWAY DISPOSABLE CONTAINER
K072667 · Solutions, Inc. · Oct 2007
ON THE GO SHARPS
K070577 · Medport, Inc. · Jul 2007

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K081449 · ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
Download PDF FDA Summary Ultimed, Inc.