Atlas FDA

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

Chad Therapeutics, Inc. · Predicate Candidate Screening

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

70 daysmedian FDA review time
180 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K081176FLOCHANNELChad Therapeutics, Inc.2008-07-28940
K070740CHAD THERAPEUTICS BONSAI MODEL 800Chad Therapeutics, Inc.2007-05-07520
K042142CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700SChad Therapeutics, Inc.2004-09-20420
K033364CHAD THERAPEUTICS SAGEChad Therapeutics, Inc.2004-05-112030
K020475CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511Chad Therapeutics, Inc.2002-07-051430
K013472TOTAL O2Chad Therapeutics, Inc.2001-11-28410
K010389CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411Chad Therapeutics, Inc.2001-03-23420
K003455MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401Chad Therapeutics, Inc.2000-12-06291
K000890CHAD THERAPEUTICS OXYMATIC MODEL 401Chad Therapeutics, Inc.2000-06-16881
K971889CHAD TOTAL O2 DELIVERY SYSTEMChad Therapeutics, Inc.1997-11-171800
K884562OXYMATIC-24Chad Therapeutics, Inc.1989-01-09700
K854239OXYCOILChad Therapeutics, Inc.1985-11-14240
K852650OXYMATICTM ELECTRONIC OXGYEN CONSERVERChad Therapeutics, Inc.1985-08-13530
K842968CHAD ADJUSTABLE CANNULAChad Therapeutics, Inc.1984-08-29300
K841901OXYMIZER FLOW RESTRICTORChad Therapeutics, Inc.1984-07-23770
K834588OXYMIZER-PENDANTChad Therapeutics, Inc.1984-03-19810
K830009OXYMIZERChad Therapeutics, Inc.1983-04-02890

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