Atlas FDA

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

Getinge Sourcing, LLC — Predicate Candidate Screening

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

166 daysmedian FDA review time
435 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K153713Getinge Series Warming CabinetGetinge Sourcing, LLC2016-06-071660
K122625GETINGE 800HC- SERIES STEAM STERILIZERGetinge Sourcing, LLC2013-05-222670
K120532GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEMGetinge Sourcing, LLC2013-05-024350
K122071GETINGE 400HC-E / SERIES STEAM STERILIZERGetinge Sourcing, LLC2013-03-122390
K120441GETINGE 700HC-E SERIES STEAM STERILIZERGetinge Sourcing, LLC2012-05-311080
K103504GETINGE 400HC/500HC SERIES STEAM STERILIZERGetinge Sourcing, LLC2011-03-161100
K070657GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZERGetinge Sourcing, LLC2007-04-05270

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