CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) (K231207): indications, design and recorded evidence

Computed exact-code research

This decision beside its recorded product-code cohort

The 2021–2025 complete-year cohort contains 91 selected decisions under primary code DQK. 91 have valid reported receipt/decision pairs; 0 pairs are missing or invalid.

Calendar elapsed days: lower quartile 68.5, median 113.0, upper quartile 172.0. These are recorded calendar differences, not active FDA review time.

The table shows the named decision and up to four latest exact-code research records through 2026-09-27. It can include partial-year records outside the complete-year cohort. The quartiles above use the full stated cohort, not this displayed selection.

Use this comparison: select a record to investigate, read its actual indications and design, and document differences. A shared code or elapsed period cannot establish its relevance to your device.

Calendar elapsed days are not active FDA review time, a promised schedule or a success probability. The selection includes only the stated recorded decisions, not all applications. Latest records can postdate the named historical decision and are contextual research, not its predicates. Shared codes, summaries and observed records do not prove equivalence, current market availability, buyer applicability or predicate suitability.

Known facts and deciding inputs

Known context: US. Confirm the organisation’s role, relevant activities and markets against the cited criteria.

Prepare a differences and evidence worksheet

Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.

1. Indications and users — what differs in our product?

   Compare the recorded indication, population, body site and use environment with your proposed label. Record each change instead of assuming the primary code settles intended use.

   Useful evidence: Our proposed indication, user/population and use environment beside this exact recorded indication.

2. Design and operating principle — what differs in our product?

   Compare physical design, materials, energy, accessories and operating principle with your design. Ask which documented differences change the evidence scope.

   Useful evidence: Design description, materials/components, accessory list and a differences matrix.

3. Non-clinical evidence actually described — what differs in our product?

   Treat these as documented evidence themes in this case, including any limitations or negative statements. Ask which protocols, design inputs and acceptance rationale would be justified for your product; these excerpts are not a mandatory test panel.

   Useful evidence: Existing protocols/results and design-specific evidence gaps, with standard editions and scope reviewed separately.

4. Performance evidence actually described — what differs in our product?

   The source labels this section as performance data. Determine which described evidence is bench, software, biological or clinical from the actual narrative and original tables; the section label alone does not settle that distinction or prescribe your testing.

   Useful evidence: The cited narrative and full tables, underlying protocols/results and a reviewed comparison with the proposed product.

5. Clinical evidence or its stated absence — what differs in our product?

   Preserve whether the summary describes clinical evidence or says none was performed. This recorded case does not determine whether your product needs clinical evidence.

   Useful evidence: Your proposed claims and supporting evidence, plus a reviewed rationale for clinical-evidence needs.

Work packages and dependencies

• Conditional: Indication, design and evidence-gap comparison — Compare the named summary and underlying official records with the proposed product; document the differences, applicable route questions and evidence gaps before agreeing submission or testing deliverables.
• Optional: User, critical-task and use-environment differences — The recorded source mentions this evidence topic, including possible negative statements. Discuss this package only if the proposed product’s design/use, source differences and current requirements justify it; the recorded case is not a mandatory testing checklist.

What needs to happen first

• FDA 510(k) Submission Services → Usability / Human Factors Testing: Define the proposed indication/design and compare the original source context; commission this optional work only after its separate evidence need is justified.

Questions for providers

• Which specific differences from the cited indication, design and operating principle change our proposed evidence work?
• What source limitations or missing protocols/results must be resolved before treating this recorded evidence as comparable?
• Which additional records and current guidance support the proposed route, and how will the comparison avoid assuming predicate suitability?