Back to free search
Home / Search / K012429

SURESET INFUSION SET, MODEL 8023

Applied Diabetes Research, Incorporated · Class II · Cleared Nov 6, 2001

K-numberK012429
Device nameSURESET INFUSION SET, MODEL 8023
ApplicantApplied Diabetes Research, Incorporated
Product codeFPA
Device classClass II
Decision dateNov 6, 2001
DecisionSubstantially Equivalent
Regulation880.5440
AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

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 →

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

14-day free trial. No setup. Cancel anytime.

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 →