Core report contents
- Target device definition and intended-use assumptions.
- Candidate predicate and comparator table with source links.
- Product-code, regulation, panel, and device-name clues.
- Difference worksheet for intended use, technology, materials, software, performance, and labeling.
- Open questions for the consultant or RA/QA reviewer.
Predicate versus comparator
A candidate predicate is a review hypothesis, not a conclusion. A comparator may still be useful for market, technical, safety-history, or claim-boundary context even if it is not the right predicate candidate.
The report should preserve the difference between the two. Calling every similar device a predicate too early creates false confidence and can hide the questions that matter most.
What to extract from FDA records
| Field | Why it belongs in the report |
|---|---|
| K number | Lets reviewers trace the exact 510(k) record. |
| Applicant and device name | Shows who submitted the record and what device identity was used. |
| Product code and regulation clue | Helps group candidate records without deciding applicability. |
| Decision date and 510(k) type | Shows timing and submission context. |
| 510(k) Summary or public documents | May expose intended use, technological characteristics, and comparison language. |
Difference worksheet
- Intended use and indications for use.
- Operating principle and technological characteristics.
- Materials, sterility, reprocessing, software, cybersecurity, and connectivity.
- Performance testing clues and standards questions.
- Known safety-history or recall review points that need qualified interpretation.
What TrueMedDevice can prepare
TrueMedDevice prepares the predicate research handoff: source ledger, candidate comparator shortlist, public 510(k) records, product-code clues, difference worksheet, safety-history review points, and open questions for qualified review.
Source ledger
What it can tell you
FDA's public explanation of the 510(k) program, substantial equivalence concept, and legally marketed predicate comparison.
What it cannot decide
Whether your device is eligible for 510(k), which predicate is suitable, or whether substantial equivalence can be demonstrated.
What it can tell you
Content concepts FDA identifies for 510(k) submissions, including device description, predicate devices, labeling, and performance data.
What it cannot decide
Whether your content, testing, comparison, or evidence package is sufficient.
What it can tell you
FDA's public guidance page on finding and using predicate devices in a 510(k) context.
What it cannot decide
Which candidate should be used as the predicate for your product.
What it can tell you
FDA's explanation of the decision points used in substantial equivalence review.
What it cannot decide
How FDA will evaluate your specific device, differences, data, or intended use.
Frequently asked questions
Can TrueMedDevice choose my 510(k) predicate?
No. TrueMedDevice can prepare a source-backed shortlist and difference worksheet for qualified review. Predicate selection and substantial equivalence strategy remain professional judgments.
Should a predicate research report include only one device?
Usually it should preserve a shortlist until a qualified reviewer narrows the strategy. A one-device report can hide important alternatives and differences.
Does a similar product code prove predicate suitability?
No. Product-code similarity is only one clue. It does not decide intended-use fit, technology differences, evidence needs, substantial equivalence, or pathway.
Need the 510(k) research handoff before the consultant call?
Prepare the source-backed shortlist, difference worksheet, product-code clues, and reviewer questions before paid expert time starts.
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