Decision Date2021-12-16
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
UltiCare Disposable Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is Ultimed Incorporated. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K213407. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UltiCare Disposable Pen Needles?
UltiCare Disposable Pen Needles is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Ultimed Incorporated. The 510(k) number is K213407.
When did UltiCare Disposable Pen Needles receive FDA 510(k) clearance?
UltiCare Disposable Pen Needles received FDA 510(k) clearance on 2021-12-16, under 510(k) number K213407.
Who is the listed applicant for UltiCare Disposable Pen Needles?
The FDA 510(k) record lists Ultimed Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UltiCare Disposable Pen Needles?
The FDA product code for UltiCare Disposable Pen Needles is FMI.
Related Devices (Code: FMI)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.