510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,569

176,366 records, page 3178 of 3528

510(k) clearances, page 3178 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K823715	Single Access Device (Ssad)	Samaritan Hospital	KOC	Class II	1983-02-07
K823712	Bel Blood Level Detector	R. Scott Bell	DTW	Class II	1983-02-07
K823693	Myelography Needle	Ocean Medical Products, Ltd.	FMI	Class II	1983-02-07
K823482	101 Universal Endoprosthesis	Intermedics Orthopedics	KWY	Class II	1983-02-07
K823467	Auto-TENS Model I Dispos. Single Chan	Cbc Corp.	GZJ	Class II	1983-02-07
K823420	Kinematic II Knee System	Howmedica Corp.	KRO	Class II	1983-02-07
K823352	Immu-Trace Tri-Rac R Tri-Level Controls	American Dade	JJY	Class I	1983-02-07
K822335	Audit	Axonics, Inc.	EWO	Class II	1983-02-07
K823655	Book on Mgmt. of the Burn Patient	Fred Sammons, Inc.			1983-02-03
K823653	Thinning Solution Salvent Based Coat-Mat	Fred Sammons, Inc.			1983-02-03
K823652	Primary Solution Salvent Based Coat- Met	Fred Sammons, Inc.			1983-02-03
K823651	Scissors	Fred Sammons, Inc.			1983-02-03
K823643	Inflatable Pillow	Fred Sammons, Inc.			1983-02-03
K823631	Non-Slip Vinyl Bath Mat	Fred Sammons, Inc.			1983-02-03
K823598	Large Terrycloth Bib	Fred Sammons, Inc.			1983-02-03
K830154	Colles Fracture Frame	Richard'S Medical Equip., Inc.	JEC	Class II	1983-02-02
K830146	Program. Treadmill Controller #645	Quinton, Inc.	IOL	Class I	1983-02-02
K823465	Auto-TENS Model II Single Channel	Cbc Corp.	GZJ	Class II	1983-02-02
K823464	Auto-TENS Model IV -Dual Channel Full	Cbc Corp.	GZJ	Class II	1983-02-02
K823389	Sodium/potassium/ionized Calcium Analyz	Nova Biomedical Corporation	JFP	Class II	1983-02-02
K830192	Mac Lee Ui Urine Collection Bag	Mac Lee Medical Products	KNX	Class II	1983-02-01
K830098	Phonic Ear	Phonic Ear, Inc.	ESD	Class I	1983-02-01
K823930	Hematology Quality Control Mixture	Fisher Scientific Company L.L.C.	GJP	Class II	1983-02-01
K823870	Beta Thalquik Column #5341	Helena Laboratories, Corp.	JPD	Class II	1983-02-01
K823869	Glyco Hb Quik Column Procedure	Helena Laboratories, Corp.	LCP	Class II	1983-02-01
K823172	Medox Oxygen System	Mepecc Intl.	CAW	Class II	1983-02-01
K823067	Model F1 Hearing Aid	Katz Hearing Aid Center	ESD	Class I	1983-02-01
K830132	Arterial Blood Filter Af-1040-Af-1040Bl	American Bentley	DTM	Class II	1983-01-28
K830131	Arterial Blood Filter Af-1025-Af-1025Bl	American Bentley	DTM	Class II	1983-01-28
K830119	Needle Catheter Jejunostomy Kit	Biosearch Medical Products, Inc.	KNT	Class II	1983-01-28
K830104	Serum Iron Diagnostic Test Kits	Sclavo, Inc.	CEM	Class II	1983-01-28
K830101	Colorimeters Series One 12	Innotron of Oregon, Inc.	JJQ	Class I	1983-01-28
K830097	Aufranc-Turner Ats Metal Backed Acetabu	Howmedica Corp.	DXQ	Class II	1983-01-28
K830096	Phadebas & Phadezyme Rast Allergen Disc	Pharmacia, Inc.	DHB	Class II	1983-01-28
K830095	Rapid Chem Analyzer II	Macomb Chemical Co.	JJF	Class I	1983-01-28
K830093	Usci Electronic Manometer	C.R. Bard Inc	DRS	Class II	1983-01-28
K830085	Collar Button Vent Tube	Treace Medical, Inc.	ETD	Class II	1983-01-28
K830049	Advance Emit-Cad Disopyramide Control	Syva Co.	LAS	Class I	1983-01-28
K830036	Neonatal Ntsh Radioimmunoassay Sys	Corning Medical & Scientific	JLW	Class II	1983-01-28
K830035	Sopheia Digitoxin Eia Kit & Components	Siemens Healthcare Diagnostics Inc.	LFM	Class II	1983-01-28
K830032	Total Iron Binding Capacity Test	Sclavo, Inc.	JQF	Class I	1983-01-28
K830031	Acrylic Sheet, Plexiglass Mc	Summit Orthodontic Services, Inc.			1983-01-28
K823939	Wako Insulin Test	FUJIFILM Healthcare Americas Corporation	CFP	Class I	1983-01-28
K823936	CPAP Infant Nasal Cannulae Set	Ackrad Laboratories	BZD	Class II	1983-01-28
K823929	Multianalyte Controls-All Kinds	Fisher Scientific Company L.L.C.	JJY	Class I	1983-01-28
K823908	Grommet Vent Tube	Treace Medical, Inc.	ETD	Class II	1983-01-28
K823907	Collar Button Vent Tube	Treace Medical, Inc.	ETD	Class II	1983-01-28
K823887	Advance Emit Cad Disopyramide Assay	Syva Co.	KLR	Class II	1983-01-28
K823883	Ultrazyme Plus Gamma-Gt, #64959/65032	EMD Millipore Corporation	JQB	Class I	1983-01-28
K823771	Spirotech 300	Spirotech, Inc.	BTY	Class II	1983-01-28