Atlas FDA

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

Soredex Palodex Group OY · Predicate Candidate Screening

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

54 daysmedian FDA review time
150 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K110839SCANORA 3DSoredex Palodex Group OY2011-06-30970
K073350SCANORA 3DSoredex Palodex Group OY2007-12-19200
K070304DIGORA PCT/DIGIPODSoredex Palodex Group OY2007-03-27550
K063459CRANEX NOVUSSoredex Palodex Group OY2006-12-26410
K043307CRANEX DSoredex Palodex Group OY2004-12-17160
K040382CRANEX BASEX D OR CRANEX EXCEL DSoredex Palodex Group OY2004-07-131470
K041050DIGORA OPTIME (OR DIGORA ONTIME)Soredex Palodex Group OY2004-06-15540
K033755MINRAYSoredex Palodex Group OY2004-04-291500
K012170DIGORA PCTSoredex Palodex Group OY2001-08-10290

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