Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Briox Technologies, Inc. — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

18 daysmedian FDA review time
28 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K813507INFALERTBriox Technologies, Inc.1982-01-12280
K800078BRIOX MODEL-AEROMISTBriox Technologies, Inc.1980-02-05220
K791241BRIOX MODEL 2000-CA COMPRESSOR UNITBriox Technologies, Inc.1979-07-24180
K791239BRIOX MODEL 2000-A ASPIRATOR UNITBriox Technologies, Inc.1979-07-24180
K791240BRIOX MODEL 2000-C COMPRESSOR UNITBriox Technologies, Inc.1979-07-24180
K791238BRIOX MODEL 2000-CQ QUIET COMPRESSORBriox Technologies, Inc.1979-07-24180

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda