Regulatory Reference · 24 terms defined

FDA 510(k) Regulatory Glossary

Key FDA 510(k) regulatory terms defined with real data from 166,200+ clearance records. Built for regulatory affairs professionals, medtech consultants and compliance teams preparing 510(k) submissions, identifying predicate devices and benchmarking FDA review timelines.

24
Terms defined
166k+
Records indexed

Regulatory Pathways

510(k) Premarket Notification
510(k) Premarket Notification is the FDA regulatory pathway under which manufacturers demonstrate that a...
166,200 510(k) submissions tracked in the dataset from 1976 to 2025, with...
De Novo Classification
De Novo classification is the FDA pathway for novel low-to-moderate risk medical devices with no valid...
De Novo authorizations are separate from 510(k) clearances. Cleared De Novo...
Premarket Approval (PMA)
Premarket Approval (PMA) is the most stringent FDA regulatory pathway, required for Class III high-risk...
PMA devices are not included in the 510k Database dataset. The dataset covers...

Submission Types

Abbreviated 510(k)
An Abbreviated 510(k) is a 510(k) submission format that relies on a manufacturer's conformance with...
Abbreviated 510(k) submissions appear throughout the dataset. The format is...
Predicate Device
Predicate device - a legally marketed medical device used as a reference in a 510(k) submission to...
165,719 of 166,200 submissions (99.7%) cleared via predicate-based...
Special 510(k)
A Special 510(k) is a streamlined 510(k) submission format used when a manufacturer modifies their own...
Special 510(k) submissions appear throughout the dataset. K-numbers from...
Third-Party Review
Third-party review is an FDA program under which accredited private organizations - authorized by the FDA...
3,434 of 166,200 submissions (~2.1%) used third-party review. Recent annual...
Traditional 510(k)
A Traditional 510(k) is the standard format for a 510(k) premarket notification submission, used when a...
Traditional 510(k) is the most common submission type in the 166,200-record...

Regulatory Concepts

510(k) Clearance
510(k) clearance is the FDA authorization granted to a medical device after a successful 510(k)...
165,719 of 166,200 submissions (99.7%) in the dataset have received 510(k)...
510(k) Exemption
A 510(k) exemption means a medical device is not required to submit a 510(k) premarket notification...
Class I exempt devices are not required to file a 510(k) and are generally...
Combination Product
A combination product is an FDA-regulated product that combines a medical device with a drug, biologic,...
The combination_product flag is populated for enriched records in the...
Device Classification - Class I, II and III
FDA device classification assigns every medical device to one of three risk-based classes. Class I...
The 510k Database covers Class I and Class II 510(k) submissions. Class II...
FDA Review Panel
An FDA review panel is one of 20 medical specialty groups within the Center for Devices and Radiological...
20 FDA review panels in the dataset. Obstetrics/Gynecology is the slowest at...
General Controls
General controls are the baseline FDA regulatory requirements that apply to all medical devices,...
General controls apply to all 166,200 device submissions in the dataset....
K-Number
A K-number is the unique identifier assigned by the FDA to each 510(k) premarket notification...
166,200+ K-numbers indexed in the 510k Database dataset, from K760001 (1976)...
Not Substantially Equivalent (NSE)
Not Substantially Equivalent (NSE) is the FDA determination that a 510(k) submission has failed to...
464 of 166,200 submissions (0.28%) in the dataset received a Not...
PCCP - Predetermined Change Control Plan
PCCP (Predetermined Change Control Plan) is an FDA-authorized framework allowing manufacturers of...
113 PCCP-authorized submissions in the dataset across 12 FDA panels....
Predicate Chain
A predicate chain is a sequence of predicate devices in which each 510(k) submission cites the previous...
Predicate chain analysis requires tracing K-number lineages across the full...
Product Code
A product code is a 3-character alphanumeric code assigned by the FDA to group medical devices that share...
4,615 product codes represented in the dataset across 20 FDA review panels....
Regulatory Consultant
A regulatory consultant (or regulatory affairs consultant) is a firm or individual that manages the...
11,050 submissions in the dataset identify a regulatory consultant as...
Special Controls
Special controls are device-specific FDA regulatory requirements applied to Class II devices in...
Special controls apply to all Class II devices in the dataset. Each product...
Substantial Equivalence
Substantial equivalence is the regulatory standard governing FDA 510(k) clearance. A new medical device...
99.7% of 510(k) submissions in the dataset resulted in a Substantially...

Device Types

IVD - In Vitro Diagnostic
IVD (In Vitro Diagnostic) is a medical device used to perform tests on biological samples - such as...
27,357 IVD-related submissions across Chemistry, Microbiology, Immunology,...
SaMD - Software as a Medical Device
SaMD (Software as a Medical Device) is software intended to be used for one or more medical purposes that...
SaMD devices are cleared across all FDA panels. The Radiology panel has the...
All dataset statistics referenced in this glossary are derived from the 510k Database dataset of 166,200+ FDA 510(k) submissions (1976-2025), published on Zenodo (DOI: 10.5281/zenodo.20269611). Official source: FDA 510(k) public files.