Cleared Traditional

UltiCare Disposable Pen Needles (K213407) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213407 · Ultimed Incorporated · General Hospital
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Dec 2021
Decision
58d
Days
Class 2
Risk

K213407 is an FDA 510(k) clearance for the UltiCare Disposable Pen Needles. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Ultimed Incorporated (Excelsior, US). The FDA issued a Cleared decision on December 16, 2021 after a review of 58 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 Incorporated devices

Submission Details

510(k) Number K213407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2021
Decision Date December 16, 2021
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

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 - FMI Needle, Hypodermic, Single Lumen

All 199
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K213407.
Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
K214075 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Apr 2022
Safety Pen Needle
K210864 · Sandstone Medical (Suzhou), Inc. · Feb 2022
DropSafe Safety Pen Needles
K211716 · Htl Strefa SA · Jan 2022
Blood Collection Needles
K200932 · Vacutest Kima Srl · Dec 2021
BD Nano 2nd Gen Pen Needle
K213156 · Becton, Dickinson and Company · Dec 2021
BD Nano 2nd Gen Pen Needle
K212015 · Becton, Dickinson and Company · Nov 2021

Related FDA 510(k) Regulatory Insights

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