Guide
How to find a predicate device
Start from the product code your device falls under, then read the 510(k) summaries of recent clearances in that code: each names the predicate it was compared to. Of the 14,826 510(k)s cleared 2021–2025 whose summaries we read, 75% named a single predicate, 82% of the predicates they cited were in the same product code, and 46% cited at least one of the applicant’s own earlier devices.
Figures from FDA decisions to Oct 23, 2026 recomputed weekly, last Nov 3, 2026
One predicate
75%
of 510(k)s, 2021–2025
Same product code
82%
of predicates cited
The firm’s own device
46%
of 510(k)s cite one
Median predicate age
4.3years
when cited
The search, step by step
- Find the product code. FDA classifies every device type under a three-letter product code. Search for devices like yours by name or company; their pages give their codes, and each product code page lists the regulation, class and recent decisions.
- List recent clearances in that code. Recent devices are compared against current standards and FDA’s current expectations, and they show which predicates FDA has accepted lately. The product code page lists the latest decisions and the predicates cited most in the code.
- Read their 510(k) summaries. Each summary names its predicate, usually by 510(k) number, in its comparison with the predicate. Our device pages list the predicates read from each summary, with the page they appear on.
- Follow the family tree. A predicate’s own predicates show the line it descends from. A device many later 510(k)s cite is a well-trodden comparison; see the most-cited predicates.
- Check recalls in the lineage. A recall of the predicate or its ancestors is worth knowing before you build on it; see recalls in the family tree.
- Compare intended use and technology. Substantial equivalence needs the same intended use, and technological differences that raise no different questions of safety and effectiveness. The closer the match on both, the stronger the predicate.
How many predicates does a 510(k) cite?
Most cite one. When a device combines features of two devices, or differs from its closest predicate in one respect another device covers, the summary names more than one.
| Predicates named in the summary | Share of 510(k)s |
|---|---|
| One | 75% |
| Two | 15% |
| Three | 5.2% |
| Four or more | 5.3% |
Skip the search. A 510(k) Report does it for your device: it finds the product code, reads the summaries of every candidate predicate, and ranks them side by side with their family trees’ recall history. $995, emailed as a PDF, usually within a few hours.
How often is the predicate the company’s own device?
Often. 46% of the 510(k)s cleared 2021–2025 cite at least one of the applicant’s own earlier devices, and 41% of all predicate citations are to the citing company’s own devices. A cleared device of your own in the same code is usually the first predicate to consider, because you hold its design and test data.
How old are predicates?
The median predicate was 4.3 years old when it was cited; half were between 1.9 and 8.8 years old, and 21% were more than ten years old. An old predicate is still a legal predicate, but the comparison has to bridge every change in technology and standards since it was cleared.
Which predicates were cited most in the last twelve months?
- K230052Inogen Rove 6Inogen, Inc. · 20236citations
- K191243HEDRON Cervical SpacersGlobus Medical, Inc. · 20196citations
- K241322Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)Joytech Healthcare Co., Ltd. · 20246citations
- K051218Modification to: Unicap Specific IgePharmacia Diagnostics AB · 20056citations
- K241846E3D™-C Interbody SystemEvolution Spine · 20245citations
- K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM)…Medtronic Sofamor Danek · 20165citations
- K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O · 20225citations
- K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 20235citations
- K223494CD Horizon Spinal SystemMedtronic · 20235citations
- K242850Wearable breast pump (model W8)Shenzhen TPH Technology Co., Ltd. · 20254citations
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
Predicates are the devices each 510(k) summary claims equivalence to, read from 14,826 summaries of 510(k)s cleared 2021–2025 (22,652 citations) and checked against FDA’s records; see how they are read and checked. A company’s own devices are those filed under the same applicant name. Ages run from the predicate’s decision to the citing device’s. The figures are recomputed from FDA’s records every week; see the methodology.