510(k)上市前通知
510(k) is a premarket notification submitted to the U.S. Food and Drug Administration to demonstrate that a medical device is substantially equivalent to an already legally marketed predicate device. In regulatory affairs and translation work, it appears in submission dossiers, device descriptions, indications, and labeling that must be prepared in English or aligned with U.S. submission language for market clearance by the agency.
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
Translators encounter 510(k) terminology when localizing regulatory dossiers, device descriptions, intended-use statements, and labeling for U.S.-bound submissions. The term often appears alongside predicate-device comparisons, indications, and performance data; translators must keep medical claims consistent with FDA submission language, approved indications, and the terminology used in the source engineering documentation received from the manufacturer.
Translation checks
A common error is translating 'substantial equivalence' as 'identical' or treating 510(k) as an approval rather than a clearance. This misrepresents the regulatory status and can affect marketing or labeling claims; inconsistent use of 'predicate device' also confuses reviewers and may trigger additional questions during the submission process from the agency.
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
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
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.