K-number	K213018
Device name	Auxilock GFS Mini, GFS II Large, and GFS Ultimate
Applicant	Auxein Medical Private Limited
Product code	MBI
Device class	Class II
Decision date	Nov 18, 2022
Decision	Substantially Equivalent
Regulation	888.3040

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 →

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 →

Auxilock GFS Mini, GFS II Large, and GFS Ultimate

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