K-number	K250700
Device name	Pen Injector Needle 32.5
Applicant	Terumo Corporation
Product code	FMI
Device class	Class II
Decision date	Nov 21, 2025
Decision	Substantially Equivalent
Regulation	880.5570

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

Pen Injector Needle 32.5

Everything you need for a 510(k) submission. Nothing you don't.