A predicate device is a legally marketed medical device that a manufacturer references to demonstrate substantial equivalence in a 510(k) premarket submission in the United States. In regulatory translation, the term appears in device descriptions, comparison tables, intended-use statements, 510(k) summaries, and equivalence rationales where the sponsor must identify the predicate and explain technological, biological, and labeling differences to support clearance.
In 510(k) projects, localization teams translate predicate device comparison tables, intended-use wording, labeling similarities and differences, and regulatory rationale sections for English-speaking markets or from English into other languages. These texts require close coordination with regulatory consultants because changing wording in a comparison table can alter the claimed equivalence, affect whether the submission is accepted, or create inconsistencies between translated and source documentation.
A common error is translating 'predicate device' as 'predecessor device' or 'reference product,' which blurs the 510(k) concept of substantial equivalence. Another error is omitting the term 'legally marketed' or changing intended-use wording in comparison tables, making the translated submission inconsistent with the regulatory claim and harder to defend during agency review.
FDA, CE/MDR and NMPA reviewers assess the submitted wording itself. Regulatory bodies require traceable, accountable translation, and an inconsistent term can delay or fail a submission.
Angel Translation locks terms like this into a project terminology base before expert review begins, so the same source term resolves to the same target term across every document in a submission — and stays consistent in the next revision. See the 8-step AI + expert workflow.
Send us the files. Acknowledged in 4 hours, quoted in 24.
Request a Quote →Life Science solutions →