Atlas FDA

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

Hygia Health Services, Inc. · Predicate Candidate Screening

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

229 daysmedian FDA review time
252 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K100523ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SHygia Health Services, Inc.2010-05-04690
K090074HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOTHygia Health Services, Inc.2009-04-221000
K080424HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1Hygia Health Services, Inc.2008-05-281030
K053575HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVEHygia Health Services, Inc.2006-02-15550
K041867HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHSHygia Health Services, Inc.2004-09-10630
K032821HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFFHygia Health Services, Inc.2003-12-05910
K012715HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR IIHygia Health Services, Inc.2003-08-017170
K021509HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 506Hygia Health Services, Inc.2002-12-242290
K012650HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAPHygia Health Services, Inc.2002-04-122420
K012651HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELSHygia Health Services, Inc.2002-04-122420
K012654HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEHygia Health Services, Inc.2002-04-122420
K012657HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAPHygia Health Services, Inc.2002-04-122420
K012956HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT Hygia Health Services, Inc.2002-04-112190
K012417HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS Hygia Health Services, Inc.2002-04-082520

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