510(k) submissions,
structured from the start.
KlearPath turns your device profile into a complete eSTAR-formatted 510(k) submission — with every claim traced back to the exact input and source document that produced it.
The submission process is broken.
Regulatory consultants charge $25,000–$75,000 per submission and take months to deliver a first draft — with no transparency into which device inputs drove which claims.
Slow turnaround
First drafts take 6–12 weeks, delaying your market entry while competitors move.
Opaque process
Consultants return a document. You have no visibility into how claims were derived from your specifications.
Expensive iteration
Every change — a predicate swap, a spec update — triggers a new billable engagement.
The KlearPath approach
One Device Profile.
Every submission section.
You build a persistent Device Profile — device name, intended use, technological characteristics, performance testing, predicates. KlearPath uses that profile to generate structured eSTAR content for each required section of the 510(k), ready for your regulatory team to review.
Change a predicate, update a spec, add a sterilization method — the submission regenerates from the updated profile in seconds, not weeks.
What sets KlearPath apart
Full traceability, by design.
Every claim in a KlearPath-generated submission links back to the specific Device Profile field version and source document that produced it. Not a black-box LLM output — a traceable, auditable record.
Field-level provenance
Each generated statement is attributed to the exact input field and value it came from — so you know precisely what to update if a spec changes.
Source document linkage
Attach bench test reports, IFUs, labeling, and predicate decision summaries. Generated claims reference the documents they draw on.
Version history
The Device Profile tracks field changes over time. Earlier submission drafts remain tied to the inputs that existed when they were generated.
Reviewer-ready output
Output follows eSTAR section structure, so FDA reviewers and your regulatory team see a document in the expected format — not raw AI output.
Who it's for
Built for medical device companies pursuing nIVD clearance.
KlearPath is purpose-built for the non-in vitro diagnostic (nIVD) 510(k) pathway — the submission type for instruments, implants, software-driven devices, and other Class II medical devices that aren't laboratory diagnostics.
Startups
First-time submitters who need structure and guidance without a full regulatory affairs team on staff.
Regulatory teams
In-house RA professionals who want to accelerate first-draft generation and spend time on review, not formatting.
CROs & consultants
Contract research organizations managing multiple client submissions who need a repeatable, documented workflow.
Early access
Request a Pilot
We're onboarding a small group of device companies. Tell us about your submission and we'll be in touch.