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 2026-10-12, 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 3332 of 3528

510(k) clearances, page 3332 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802150	Digital Radiography System	Philips North America LLC	JAA	Class II	1980-10-23
K802134	Jk Int'l, Inc. Soltron Uva Tanning Bed	Mottek Intl. Corp.	LEJ	Class II	1980-10-23
K802132	105Mm Spot Film Camera	Instrumentation Camera, Inc.	IZJ	Class II	1980-10-23
K802077	Unipolar to Bipolar Pulse Gen. Adapter	Cardiac Pacemakers, Inc.	DTD	Class II	1980-10-23
K802066	Endab Theophylline Enzyme Immunoassay	IMMUNOTECH s.r.o.	KLS	Class II	1980-10-23
K802047	Amx-III	General Electric Co.	IZL	Class II	1980-10-23
K802045	G.e. Scan Capability Cat.#b7815f	General Electric Co.	JAK	Class II	1980-10-23
K802041	Ampco Shave Prep Trays, Cat.#sp4020	Associated Medical Products Co.	LDQ		1980-10-23
K802039	Phenobarbital Reagent Test Kit	Beckman Instruments, Inc.	DLZ	Class II	1980-10-23
K802038	Phenytoin Reagent Test Kit	Beckman Instruments, Inc.	DID	Class II	1980-10-23
K802036	Cortisol125 Radioimmunoassay	Corning Medical & Scientific	CGR	Class II	1980-10-23
K802032	Mini Mick Applicator	Mick Radio-Nuclear Instruments, Inc.	JWJ	Class II	1980-10-23
K801983	Scott Needle & Scott Mick Implanter	Mick Radio-Nuclear Instruments, Inc.	IWJ	Class I	1980-10-23
K801973	In-Line Scan Head Mark IV Duplex Ultra	Advanced Technology Laboratories, Inc.	ITX	Class II	1980-10-23
K801972	True Spectrum Analysis/mark IV Duplex	Advanced Technology Laboratories, Inc.	IYN	Class II	1980-10-23
K801971	In-Line Scan Head Modification Mark III	Advanced Technology Laboratories, Inc.	ITX	Class II	1980-10-23
K801963	Cmv Test Kit	Immuno-Diagnostic Products, Inc.	GQH	Class II	1980-10-23
K801959	Fta-ABS Test	Immuno-Diagnostic Products, Inc.	JWL	Class II	1980-10-23
K801953	External, Temp. Portable Cardiac Gener	Telectronics, Inc.	DTE	Class II	1980-10-23
K801944	Multichannel Telemetry System	Burdick Corp.	DRG	Class II	1980-10-23
K801914	Temp Sternum Saw	Temp Medical Products, Inc.	DWI	Class I	1980-10-23
K801892	Klinar Reagent Pak, #36010	Hi Chem, Inc.	JGT	Class II	1980-10-23
K801862	Medela Electric Breast Pump	Medela AG	HGX	Class II	1980-10-23
K801818	Tenckhoff Catheter	Sil-Med Corp.	FJS	Class II	1980-10-23
K801800	Universal Temp. Pacing Elect. #080-10000	Medical Testing System, Inc.	LDF	Class II	1980-10-23
K801792	Implantable Endocardial Porous Tip Elec.	Telectronics, Inc.	DTB	Class III	1980-10-23
K801734	Imed Drop Rate Calculator #340	Imed Corp.	FLN	Class II	1980-10-23
K801675	U.i. Octoson	Ausonics Pty, Ltd.	LEJ	Class II	1980-10-23
K801667	Gamma Coat(125 I) Rubella Antibody	Clinical Assays, Inc.	GOL	Class II	1980-10-23
K801579	Vitamin B12 - No-Boil Kit	Ria Products, Inc.	CDD	Class II	1980-10-23
K801578	Combostat - No-Boil Kit	Ria Products, Inc.	CDD	Class II	1980-10-23
K801455	Lead, Endocardial, Tined, Bipolar, 5Mm	Pacesetter Systems	DTB	Class III	1980-10-23
K801417	Pacepath Model 819	Pacesetter Systems	DTB	Class III	1980-10-23
K801820	Foley Catheterization Tray	Abco Dealers, Inc.	KOD	Class II	1980-10-21
K801787	Urinary Catheter Care Trays #3700&3710	The Healthcare Group Laboratories, Inc.	KOD	Class II	1980-10-21
K801785	Urethral Catheterization Trays	The Healthcare Group Laboratories, Inc.	KOD	Class II	1980-10-21
K802622	Emit-Stm Urine Controls	Syva Co.			1980-10-20
K802120	Hepa-Shure -L	Nuclear Medical Laboratories, Inc.	JJK	Class I	1980-10-20
K802290	Regional Intravenous Anesthesia Kit	Stanco Medical, Inc.	CAZ	Class II	1980-10-17
K802269	Figuretrim	Colne Medical Co., Ltd.	IPF	Class II	1980-10-13
K802378	Quick Prime Lines, #'S Bpl-12, Bpl-48 &	Bentley Laboratories, Inc.	DWF	Class II	1980-10-10
K802375	Ampco Skin Scrub Tray	Associated Medical Products Co.	FMC	Class I	1980-10-10
K802366	Nu-Born Baby Bath Kit	American Hospital Supply	LDQ		1980-10-10
K802362	Alginate Impression Material	Dentsply Intl.	ELW	Class II	1980-10-10
K802358	Oreia-Q-Dig	Organon LLC	KXT	Class II	1980-10-10
K802343	Pregna B-Anti Human Chorionic Gonadotro	Intl. Diagnostic, Inc.	JHJ	Class II	1980-10-10
K802340	Specimen Set	American Pharmaseal Div. Ahsc	FMH	Class I	1980-10-10
K802338	Torque Control Balloon Catheter	Cordis US Corp.	DYG	Class II	1980-10-10
K802335	Whirlpool Bathing Unit-#2001	Aqua Care Corp.	ILJ	Class II	1980-10-10
K802334	In-Home Early Pregnancy Test Kit	Health Diagnostics Corp.	JHJ	Class II	1980-10-10