Eleven required elements
Device name, classification, predicate, substantial equivalence, labeling, manufacturing, and more — all present, or the pack does not release.
The most rigorous 510(k) submission package a device manufacturer can commission.
FDA 510(k) Submission Engine assembles a documentation-complete, RTA-resistant 510(k) package — every statutory element, every required search, the eSTAR template, the predicate matrix, and the acceptance checklist — checked against the letter of 21 CFR 807.87 and FDA guidance before a credentialed specialist releases it.
Every element of 21 CFR 807.87eSTAR template compliancePredicate mining · SE table · special controls mappingRTA checklist validationSpecialist release on every pack
Why submissions fail
A single missing element can trigger an RTA hold and delay clearance by months.
A medical device manufacturer's 510(k) clearance is only as strong as the submission behind it. Miss one of the required elements, skip a predicate search, misapply a special control, or fail to complete the eSTAR template correctly — and the FDA can issue a Refuse to Accept (RTA) hold before a reviewer reads the science.
Roughly one in three submissions hits an RTA hold at least once. Most manufacturers run this by hand, from memory, once or twice a year. The regulation has not been read end-to-end since the last time it mattered. That is exactly where completeness gaps hide.
FDA 510(k) Submission Engine exists to close that gap with a single, exhaustive standard applied identically to every file.
1 in 3
submissions receive an RTA hold at least once
The benchmark
Measured against the letter of the regulation — subsection by subsection.
We do not summarize the law and hope. Every pack is scored against a versioned rule pack tied to the exact text of 21 CFR 807.87 and FDA guidance. These are the provisions each pack is held to.
eSTAR template compliance
The submission is drafted into the FDA's electronic Submission Template And Resource (eSTAR) format, mandatory for nearly all 510(k)s since October 1, 2023.
Predicate device identification
A predicate device is identified with 510(k) number, product code, and substantial equivalence rationale, mined from the public 510(k) database.
RTA checklist validation
Every element of the FDA's Refuse to Accept screening checklist is verified before release — no administrative bounce.
Special controls mapping
For devices subject to special controls, the applicable FDA guidance documents and recognized consensus standards are mapped and addressed.
Labeling and indications check
Proposed labeling, instructions for use, and indications are cross-checked against the predicate and special controls for consistency.
How a pack is built
Intake to specialist release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A credentialed regulatory specialist signs every release. That order is never reversed.
01
Gap Scan
Upload device specifications and predicate information. We return a free completeness read: which statutory elements and searches you already have, and which are missing.
02
Predicate mining & evidence gathering
As your authorized clerical agent, we mine the public 510(k) database, openFDA, and FDA guidance for predicates, special controls, and recognized standards, building the evidence matrix.
03
Grounded drafting
The eleven required elements are drafted from your validated data and the 21 CFR 807.87 rule pack into field-locked eSTAR templates — no legal opinions, no invented facts.
04
Deterministic completeness gates
RTA checklist is resolved; predicate SE table is verified; special controls are mapped; labeling is cross-checked. Any failure blocks release.
05
Specialist release
A RAC-credentialed regulatory specialist reviews the exception queue and signs the release. High-risk or novel devices route to attorney review first.
06
Delivery
You receive the pack: completed eSTAR submission, predicate matrix, evidence log, RTA checklist, and acceptance calendar — ready for the manufacturer to submit under its own name.
The bar we hold
Rigor you can measure.
100%
Specialist-released
No pack ships without a human signature.
10 days
Standard SLA
From complete intake to released pack.
<1%
RTA-hold target
Tracked against a gold-standard pack library.
3
Database sources
510(k) database · openFDA · FDA guidance, every applicable file.
Why FDA 510(k) Submission Engine
Built to be the most thorough option a manufacturer has.
Documentation-complete, by design
The deliverable is completeness itself — every statutory element and search accounted for or explicitly exception-coded. Nothing is left implicit.
Deterministic, not vibes
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.
In its lane, on purpose
We prepare documentation and run searches as your clerical agent. We never submit to FDA, give legal advice, or act as the manufacturer of record.
Engagement
Flat fee, per released pack. No hourly billing, ever.
Simple, predictable, and aligned with a documentation standard — not a cut of any clearance.
- A free Gap Scan before you commit — see exactly what is missing.
- One flat fee per released 510(k) Submission Package; disclosed pass-through search fees.
- Optional fixed-fee attorney review for high-risk or novel devices.
- Optional Pre-Sub (Q-Sub) Add-on for FDA meeting preparation and minutes.
FAQ
Questions, answered precisely.
Is FDA 510(k) Submission Engine a law firm?
No. FDA 510(k) Submission Engine, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you before FDA. Attorney review is available and recommended for high-risk or novel devices.
Do you submit the 510(k) to FDA?
Never. The manufacturer remains the legal submitter of record. We prepare the documentation package; you submit it under your own name.
What makes a pack 'complete'?
Completeness is defined by the regulation: the eleven 21 CFR 807.87 elements present, eSTAR template compliance, predicate identification, RTA checklist resolved, special controls mapped, and labeling cross-checked. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is ten business days from complete intake to a specialist-released pack. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per released pack, plus disclosed pass-through search costs. No hourly billing and no percentage of any clearance or revenue.
See what's missing before it costs you a clearance.
Start with a free Gap Scan. Send your device specifications and predicate information and we'll return a completeness read against every element of 21 CFR 807.87.
Documentation-completeness service · not legal advice · the manufacturer submits every notice.