K-number	K151498
Device name	Breathing circuit bacterial/viral filter
Applicant	Zhejiang Haisheng Medical Device Co., Ltd.
Product code	CAH
Device class	Class II
Decision date	Dec 18, 2015
Decision	Substantially Equivalent
Regulation	868.5260

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 →

Breathing circuit bacterial/viral filter

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