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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Sunrise Medical Hhg, Inc. · Predicate Candidate Screening

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

139 daysmedian FDA review time
350 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K083249QUICKIE RHYTHMSunrise Medical Hhg, Inc.2008-12-23490
K012437DEVILBISS SLEEP RECORDER MODEL # RM60Sunrise Medical Hhg, Inc.2002-07-163500
K020329DEVILBISS PD1000Sunrise Medical Hhg, Inc.2002-06-191392
K020900DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEMSunrise Medical Hhg, Inc.2002-06-03750
K011229DEVILBISS 9000 SERIES CPAP, MODEL 9001Sunrise Medical Hhg, Inc.2001-07-11790
K003626DEVILBISS HUMIDIFIERSunrise Medical Hhg, Inc.2001-05-041610
K993492DEVILBISS NEBULIZER MODEL 800Sunrise Medical Hhg, Inc.2000-04-211890
K991722DEVILBISS 5 LITER OXYGEN CONCENTRATORSunrise Medical Hhg, Inc.1999-11-031671
K982304DEVILBISS SUCTION UNITSunrise Medical Hhg, Inc.1998-09-25863
K981602DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATORSunrise Medical Hhg, Inc.1998-07-17730

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