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

DMG Chemisch-Pharmazeutische Fabrik GmbH · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213201DeltaFil, DeltaFil ConditionerDMG Chemisch-Pharmazeutische Fabrik GmbH2022-06-012450
K183337LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2DMG Chemisch-Pharmazeutische Fabrik GmbH2019-05-291770
K991172IONOSIT BONDDmg Chemisch Pharmazeutische Fabrik GmbH1999-05-17400
K924830LUXATEMP AUTOMIXDmg Chemisch Pharmazeutische Fabrik GmbH1994-04-295810

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