Predicate Device对照器械
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.
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Where this term appears
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.
Translation checks
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.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
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Walvax Biotechnology
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Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.