Guide
510(k) or De Novo: what if there is no predicate?
A 510(k) needs a predicate: a legally marketed device the new one is substantially equivalent to. When none exists and the device is low to moderate risk, a De Novo request asks FDA to classify a new device type instead. FDA granted 172 De Novo requests in 2021–2025. The median took 318 days from receipt to grant, against 133 for a 510(k).
Figures from FDA decisions to Oct 23, 2026 recomputed weekly, last Nov 3, 2026
De Novo grants, 2021–2025
172
26 in 2025
Median De Novo review
318days
510(k): 133 days
New product codes
170
created by grants, 2021–2025
Later cited as a predicate
64%
of grants 2016–2023
When is a De Novo the route?
When the search for a predicate comes up empty: no device in your product code, or any other, shares your device’s intended use, or your technology raises questions about safety and effectiveness that the closest devices do not. A 510(k) filed without a real predicate ends in a not-substantially-equivalent decision, and the De Novo request is then the usual next step; it can also be filed directly.
The De Novo route costs more and takes longer: the median De Novo took 318 days in 2021–2025, and half took between 233 and 469. A Pre-Submission meeting with FDA is the usual way to settle which route applies before filing.
What happens after a De Novo grant?
Each grant creates a new classification, usually with its own product code, and the granted device becomes a predicate later 510(k)s can cite. Of the 242 De Novo devices granted 2016–2023, 155 (64%) have since been cited as a predicate. The 170 product codes created by De Novo grants in 2021–2025 have since had 240 510(k) clearances, and 1.7% of recent 510(k)s cite a De Novo device as a predicate.
De Novo grants per year
26in 2025
2026 to Oct 23, 2026, outlined.
Not sure there is a predicate? A 510(k) Report searches every candidate for your device and tells you whether the closest match is close enough for a 510(k), or whether the evidence points to a De Novo. $995, emailed as a PDF, usually within a few hours.
Which De Novo devices are cited most?
- DEN010002Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 200113cite it
- DEN200031BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 202113cite it
- DEN070013ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 200812cite it
- DEN170073ContaCTViz.Al, Inc. · 201810cite it
- DEN160029SkinPen Precision SystemBellus Medical, LLC · 20189cite it
- DEN980001Dynamic Orthotic Cranioplasty Band; Doc BandCranial Technologies, Inc. · 19989cite it
- DEN160056Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 20179cite it
- DEN990002Kavo DiagnodentKavo America · 20008cite it
- DEN130002Tina-Quant HBA1C Gen. 2 Test SystemRoche Diagnostics · 20137cite it
- DEN070003Neurostar TMS SystemNeuronetics · 20086cite it
Recent De Novo grants
- DEN260027Elecsys HBsAg II quant II RxDxRoche Diagnostics · 2026SJM
- DEN260007SmartRead (TM) Medical Device Identifier (4100)BridgeSource Medical Corporation · 2026SJJ
- DEN250044Queen of Hearts (ACS AI ECG Model)Powerful Medical, Inc. · 2026SHS
- DEN250049Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring SystemAbbott Diabetes Care · 2026SJD
- DEN250067ReneuRx™ (Neural Ice)Brixton Biosciences · 2026SJA
- DEN250026AvuluxMatap Ii, LLC · 2026QEO
- DEN250043Qoramatic Automated Stool ManagementCm Technologies, Inc. · 2026SJB
- DEN250046Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)Vitestro · 2026SIW
- DEN250042CaRi-HeartCaristo Diagnostics, Ltd. · 2026SIU
- DEN250068OTTAVA™ Robotic Surgical SystemAuris Health, Inc., part of Johnson & Johnson MedTech · 2026SIR
- DEN250040SportSuite Vision SoftwareStryker Endoscopy · 2026SIT
- DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026SIQ
Doing this for your own device? A 510(k) Report starts from your device concept: it finds the product code and pathway, ranks candidate predicates side by side, and weighs their family trees’ recall history and review times. $995, emailed as a PDF, usually within a few hours.
How these figures are computed
De Novo grants are the DEN decisions in FDA’s records (465 in all); review days run from receipt to decision. A product code counts as created by a De Novo when FDA’s records hold no earlier decision in it. “Later cited” counts any later device whose summary names the De Novo device as a predicate. The figures are recomputed from FDA’s records every week; see the methodology.