K-number	K010616
Device name	DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
Applicant	Hmi Industries, Inc.
Product code	FRF
Device class	Class II
Decision date	Mar 28, 2001
Decision	Substantially Equivalent
Regulation	880.5045

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 →

DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A

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