DevicePath: FDA device classification and 510(k) predicate search in seconds
Describe your device in plain language and DevicePath returns its likely FDA device class, candidate product codes, the probable premarket pathway, real 510(k) predicate candidates with K-numbers, and high-level EU MDR and UKCA considerations — open-source MedTech regulatory triage for teams that need an answer today.
What DevicePath gives you
Regulatory triage usually starts with a week of database searching and a consultant call. DevicePath compresses the first pass into a single description of the device and its intended use.
- Likely FDA device class (I, II or III) for your intended use
- Candidate FDA product codes with the regulation behind each
- Probable premarket pathway: 510(k), De Novo, PMA or exempt
- Real 510(k) predicate candidates with K-numbers
- High-level EU MDR and UK (UKCA / MHRA) considerations
Medical device start-ups
Get a defensible first read on class, pathway and predicates before the first regulatory invoice.
Digital health and SaMD teams
See how intended-purpose wording moves software between unregulated, 510(k) and EU MDR Rule 11 territory.
Small-to-mid-size manufacturers
Run the same triage across a portfolio so every programme is compared on one consistent basis.
Regulatory triage explained
Practical writing on FDA device classification, 510(k) predicate search and Software as a Medical Device routes across the US, EU and UK.
Design history file requirements: what belongs in a medical device DHF
What a design history file must contain under 21 CFR 820.30 and ISO 13485, how the DHF relates to the DMR and DHR, and how to keep it audit-ready.
Read articleUKCA marking for medical devices: MHRA registration and the route to Great Britain
What UKCA marking requires for medical devices, how MHRA registration and UK Responsible Person duties work, and how the Great Britain route differs from EU MDR.
Read articleEU MDR classification rules: how to classify a medical device under Annex VIII
A practical walkthrough of EU MDR classification: the Annex VIII rules, Class I to III, Rule 11 for software, and what each class means for conformity assessment.
Read articleFDA premarket pathways explained: 510(k), De Novo, PMA and exempt
How to choose between 510(k), De Novo, PMA and exemption — what each FDA premarket pathway requires, how long it takes, and how to tell which one fits your device.
Read articleSoftware as a Medical Device: FDA, EU MDR and UKCA routes for SaMD teams
How SaMD is classified and regulated across the US, EU and UK — FDA pathways for software, EU MDR Rule 11, and UKCA and MHRA considerations for digital health teams.
Read article510(k) predicate search: how to find and defend a predicate device
A practical method for 510(k) predicate search: what makes a valid predicate, how to use K-numbers and product codes, and how to document substantial equivalence.
Read articleFDA device classification: how to find your device class and product code
How FDA device classification works, how to find the right product code, and what Class I, II and III mean for your premarket pathway.
Read articleFrequently asked questions
- What is FDA device classification?
- FDA classifies devices as Class I, II or III according to risk and the controls needed to assure safety and effectiveness. The class, together with the three-letter product code, determines the premarket pathway: exempt, 510(k), De Novo or PMA.
- How do I find a 510(k) predicate device?
- Start from the product code that matches your intended use, pull legally marketed devices cleared under that code, and compare indications statements rather than product names. A valid predicate shares your intended use, and any differing technological characteristics must not raise different questions of safety and effectiveness.
- Is DevicePath really open source?
- Yes. DevicePath is an open-source regulatory triage model, free to try in the browser. It gives a defensible starting point for classification and predicate work; it does not replace regulatory counsel or a submission strategy.
- Does DevicePath cover EU MDR and UKCA?
- It returns high-level EU MDR and UK (UKCA / MHRA) considerations alongside the US output, including where EU MDR Rule 11 is likely to place decision-influencing software. Detailed EU and UK routes are covered in the EU MDR and UKCA compliance guide.
- Who is DevicePath built for?
- Medical device start-ups, digital health and Software as a Medical Device (SaMD) teams, and small-to-mid-size MedTech manufacturers who need fast, repeatable regulatory triage before spending consultant hours.
Start with the triage, then go deep
Run DevicePath for the classification and predicate shortlist, then bring MedTech Compass in for market scoring and launch sequencing across 25+ markets.