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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2044 of 3531

510(k) clearances, page 2044 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K951240	Justone	Radiometer America, Inc	JWY	Class II	1995-10-07
K951010	Chlamydia Oia	Biostar, Inc.	LJC	Class I	1995-10-07
K945517	Magnetom Vision (Project 016)	Siemens Medical Solutions USA, Inc.	LNH	Class II	1995-10-07
K943952	Disetronic D-Modem	Disetronic Medical Systems	FRN	Class II	1995-10-07
K942965	Computer Dyno/gonio/myo Graphy	Infotronic Medical Engineering	IKN	Class II	1995-10-07
K954430	Unitron Model Sound F/x	Unitron Industries, Inc.	ESD	Class I	1995-10-06
K954309	Angiorex	Toshiba Medical Systems	IZI	Class II	1995-10-06
K954235	Hollister Hydrocolloid Wound Dressing	Hollister, Inc.	FRO	Unclassified	1995-10-06
K954144	Opus Hcg Controls	Behring Diagnostics, Inc.	JJX	Class I	1995-10-06
K954137	Qbc Centrifugal Hematology Control	R & D Systems, Inc.	JPK	Class II	1995-10-06
K954125	Sauer Endoscope Guide and Intubation Aid	Karl Storz Endoscopy-America, Inc.	EOQ	Class II	1995-10-06
K953403	Deroyal Industries, Inc. Polyderm & Polyderm Border Foam Wound Dressings	DeRoyal Industries, Inc.	KMF	Class I	1995-10-06
K953398	Uniscan	Merlin Engineering Works, Inc.	LMD	Class I	1995-10-06
K953393	Tox Perfect a Tube	Chimera Research & Chemical, Inc.	DMP	Class I	1995-10-06
K953288	Diastat Vascular Access Graft	W. L. Gore & Associates, Inc.	DSY	Class II	1995-10-06
K953287	Diastat Vascular Access Graft	W. L. Gore & Associates, Inc.	DYF	Class II	1995-10-06
K953284	Trend Giardia Direct Detection Rs Test System	Trend Scientific, Inc.	MHI	Class II	1995-10-06
K953242	Symbiosis Monoplar Electrosurgical Electrodes	Boston Scientific Corporation	KNF	Class II	1995-10-06
K953220	32Mm Nickel Plated Disc Electrode	Chalgren Enterprises, Inc.	GXY	Class II	1995-10-06
K953219	22Mm Stainless Steel Disc Electrode, with Pin	Chalgren Enterprises, Inc.	GXY	Class II	1995-10-06
K953179	Clm Laryngoscope	Penlon, Ltd.	CCW	Class I	1995-10-06
K953115	Axsym Amphetamine/methamphetamine II	Abbott Medical	DKZ	Class II	1995-10-06
K952775	Deroyal Wound Care Multidex Gel Wound Dressing	DeRoyal Industries, Inc.	MGQ	Unclassified	1995-10-06
K952661	Slt Thermalite Diode Laser Series, Diode 980, 810, 940	Surgical Laser Technologies, Inc.	GEX	Class II	1995-10-06
K952608	Mda Simplastin Ls	bioMerieux, Inc.	GJS	Class II	1995-10-06
K952532	Affinity Arterial Blood Filter	Avecor Cardiovascular, Inc.	DTM	Class II	1995-10-06
K952483	Leep System 1000	CooperSurgical, Inc.	HGI	Class II	1995-10-06
K952308	Coulter Z 1	Coulter Corp.	GKL	Class II	1995-10-06
K951684	Airperfect 1000 (Single-User System), Airperfect 2000 (Multi-User System)	Digital Air Corp.	JOW	Class II	1995-10-06
K951370	Zymed Telemetry System; Model T8010	Zymed Medical Instrumentation	DSI	Class II	1995-10-06
K945850	Braun Diacan(r) Fistula Needles	B. Braun of America, Inc.	FIE	Class II	1995-10-06
K943440	Profile 7000 C-Spine Coil	Us Asia Instruments, Inc.	LNH	Class II	1995-10-06
K954094	Ophta Sil- Punctal Plugs (Modification)	G.W.B. Intl., Ltd.	LZU	Unclassified	1995-10-05
K954049	Micro-Touch* Latex Surgical Gloves	Johnson & Johnson MEDICAL GmbH	KGO	Class I	1995-10-05
K954029	Testpack Plus Hcg Urine	Abbott Medical	JHI	Class II	1995-10-05
K954018	Avl Omni Analyzer	Avl Scientific Corp.	GKR	Class II	1995-10-05
K953563	Vanguard Xr-350 Cineangiogram Projector	Jamieson Film Co.	IZI	Class II	1995-10-05
K953541	Instant Coldgel	Prism Technologies, Inc.	IMD	Class I	1995-10-05
K953451	Uropump Tube & Damping Chamger	Life-Tech Intl., Inc.	FEN	Class II	1995-10-05
K953340	Qbc Accutube	Becton Dickinson Diagnostic Instrument Systems	GKZ	Class II	1995-10-05
K953276	Acufex Tag Delivery System	Acufex Microsurgical, Inc.	JDR	Class II	1995-10-05
K953190	Ksea Model 203200 20 Unimat	Karl Storz Endoscopy-America, Inc.	HET	Class II	1995-10-05
K953158	Hawn Universal	Metal-Tech	DZE	Class II	1995-10-05
K953105	Visualine II Benzodiazepines	Sun Biomedical Laboratories, Inc.	JXM	Class II	1995-10-05
K952983	Altr Nova 110 Hemodialyzer	Althin Medical AB an Affiliate of Baxter Intl	KDI	Class II	1995-10-05
K952982	Altrex 110 Hemodialyzer	Althin Medical AB an Affiliate of Baxter Intl	KDI	Class II	1995-10-05
K952978	Altra Flux 110 Hemodialyzer	Althin Medical AB an Affiliate of Baxter Intl	KDI	Class II	1995-10-05
K952779	Karl Storz Flexible Hysterscope	Karl Storz Endoscopy-America, Inc.	HIH	Class II	1995-10-05
K952410	Carbon Dioxide - Dst	Trace America, Inc.	KHS	Class II	1995-10-05
K952330	External Fixator	Acu Med, Inc.	JEC	Class II	1995-10-05