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

Getinge/Castle, Inc. — Predicate Candidate Screening

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

57 daysmedian FDA review time
246 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K020205CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KITGetinge/Castle, Inc.2002-06-241530
K020590MODEL 733HC GRAVITY/VACUUM STEAM STERILIZERGetinge/Castle, Inc.2002-03-20260
K012573CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 43Getinge/Castle, Inc.2001-09-05270
K003441CASTLE MODEL 233HC STEAM STERILIZERGetinge/Castle, Inc.2001-01-02570
K994314CASTLE SERIES 100HC STEAM STERILIZERSGetinge/Castle, Inc.2000-02-16560
K993242CASTLE SURGICAL LIGHT, MODEL 3000Getinge/Castle, Inc.1999-11-08420
K974084GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHTGetinge/Castle, Inc.1998-03-031250
K973225CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)Getinge/Castle, Inc.1998-02-101670
K970907CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)Getinge/Castle, Inc.1997-11-122460

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