Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Pen Injector Needle 32.5

K-Number: K250700 · 2025-11-21

Decision Date2025-11-21
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Pen Injector Needle 32.5 is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K250700. 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 Pen Injector Needle 32.5?

Pen Injector Needle 32.5 is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Terumo Corporation. The 510(k) number is K250700.

When did Pen Injector Needle 32.5 receive FDA 510(k) clearance?

Pen Injector Needle 32.5 received FDA 510(k) clearance on 2025-11-21, under 510(k) number K250700.

Who is the listed applicant for Pen Injector Needle 32.5?

The FDA 510(k) record lists Terumo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pen Injector Needle 32.5?

The FDA product code for Pen Injector Needle 32.5 is FMI.

Other records listing Terumo Corporation as applicant

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.

View all 9 devices →

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.

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.