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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1731 of 3533

510(k) clearances, page 1731 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K991719	Epistar/epistar Cse Spinal/epidural Anesthesia Administration Sets	Medimex Holfeld GmbH & Co.	CAZ	Class II	1999-08-18
K991585	Bipolar Shoulder Prosthesis	Zimmer GmbH	KWT	Class II	1999-08-18
K991283	Dyna Torq Torque Wrench, Torque Wrench	Micro Motors, Inc.	DZE	Class II	1999-08-18
K991273	Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle	Swemed Lab International AB	MQE	Class II	1999-08-18
K990565	Suzanne	Medtronic, Inc.	MNR	Class II	1999-08-18
K992515	Ebi Xfix Dfs Optirom Elbow Fixator	Ebi, LLC	KTT	Class II	1999-08-17
K992412	Ipass Bolus Tracking	Philips North America LLC	LNH	Class II	1999-08-17
K992337	Blossom Powder Free Latex Examination Gloves with Protein Content Labeling Claim 50 Mcgm or Less of Total Water Extracta	Mexpo Intl., Inc.	FMC	Class I	1999-08-17
K992200	Textured Powder-Free Latex Examination Gloves with Aloe Vera Green, Contains 50 Mcgm or Less of Total Water Extractable	Shen Wei (USA), Inc.	LYY	Class I	1999-08-17
K992152	General Purpose Transducer Standoff, Biopsy Transducer Standoff, Bi-Plane Endocavity Transducer Standoff	CIVCO Medical Instruments Co., Inc.	ITX	Class II	1999-08-17
K992006	Neuroview Instrument Holder, Model 300-33	Integra Neurocare, LLC	OCV	Class II	1999-08-17
K991980	Mammotome Hh Hand-Held Probe, Vacuum Set, Control Module, Hh Hand-Held Holster and Cables, Software Package, Footswitch,	Ethicon Endo-Surgery Inc	KNW	Class II	1999-08-17
K991873	Kmi Wrist Fusion System	Kinetikos Medical, Inc.	HRS	Class II	1999-08-17
K991785	Manual Jet Ventilator (with Regulator and Gauge), Manual Jet Ventilator (without Regulator and Gauge), Models Be 183-Sur	Instrumentation Industries, Incorporated	BTL	Class II	1999-08-17
K991764	Somatom Project 10-CT Scanners	Siemens Medical Solutions USA, Inc.	JAK	Class II	1999-08-17
K991753	Maxim Removable Molded Poly Tibia	Zimmer GmbH	JWH	Class II	1999-08-17
K991693	Two Rivers Power Lift/recline Chair	Two Rivers, LLC	INO	Class II	1999-08-17
K990359	Konica Direct Digitizer, Model Dd-341	Konica Corp.	MQB	Class II	1999-08-17
K992339	Colorsoft Prosthetic Tinted Soft Contact Lens	Colorsoft Laboratories Corp.	LPL	Class II	1999-08-16
K992048	Modification of Prompt L-Pop	Espe Dental AG	KLE	Class II	1999-08-16
K983298	Buffalo Filter Virosafe Erbium:yag Filter - #Vseyag1-4 Buffalo Filter Virosafe Erbium:yag Prefilter - #Bfeyag04pf	Buffalo Filter Co., Inc.	FYD	Class II	1999-08-16
K992462	Osteonics Universal Distal Cement Plug	Howmedica Osteonics Corp	LZN	Class II	1999-08-13
K992439	Norodyn 8000 Semg System, Nd-8000	Myotronics-Noromed, Inc.	HCC	Class II	1999-08-13
K992336	Monarch II Mini Mask	Respironics, Inc.	BZD	Class II	1999-08-13
K992120	Dynawell or Dynawell	Ekeroth Quality AB	LNH	Class II	1999-08-13
K992046	Sonoline 7Xx Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYO	Class II	1999-08-13
K992025	Precision Osteolock Femoral Stems with Pure-Fix Ha Coating	Howmedica Osteonics Corp	MEH	Class II	1999-08-13
K991972	Infant Flow System	Sensor Medics Corp.	BZD	Class II	1999-08-13
K991960	Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch	Stryker Corp.	GEI	Class II	1999-08-13
K991958	Klout Shampoo and Lice Combing Pretreatment Kit	Kiel Laboratories, Inc.	LJL	Class I	1999-08-13
K991921	Intermittent Compression Boot for OTC	Eischoco, Inc.	IRP	Class II	1999-08-13
K991893	Parallax Tracer Radiopaque Particles	Parallax Medical, Inc.	MYU	Class II	1999-08-13
K991815	Explorer 3D	Our Scientific Intl., Inc.	MUJ	Class II	1999-08-13
K991794	Endoscopic Spinal Access System	Endius, Inc.	HRX	Class II	1999-08-13
K991738	Digital Video Recording System	Kay Elemetrics Corp.	LLZ	Class II	1999-08-13
K991721	Ebi Omega 21 System	Ebi Electro Biology	MNI	Class II	1999-08-13
K991685	Halolite Aad System with Dedicated Compressor	Medic-Aid, Ltd.	CAF	Class II	1999-08-13
K991427	Paramed Paraffin Warmer	Divi Intl. Co.	IMC	Class II	1999-08-13
K990724	Conway Stuart Model 100 Irrigation Pump & Accessories	Conway Stuart Medical, Inc.	GCJ	Class II	1999-08-13
K990651	Skin 2 Forte Silicone Sheeting	United Hospital Technologies, Inc.	MDA	Class I	1999-08-13
K990180	Burnfree (4X4, 8X8, 16X24) Sterile Burn & Wound Dressing	Nortrade Medical, Inc.	MGQ	Unclassified	1999-08-13
K990179	Burnfree 1/8 Oz. Sterile Pain Relieving Gel, Model Sd	Nortrade Medical, Inc.	MGQ	Unclassified	1999-08-13
K990178	Burnfree Pain Relieving Gel, Model 4B	Nortrade Medical, Inc.	MGQ	Unclassified	1999-08-13
K984546	Biologic-Dt Machine, Model Dt-1000 and Biologic-Dt Treatment Kit, Model Dt-1000-Tk	Hemocleanse, Inc.	FLD	Class II	1999-08-13
K983577	Arthrex Meniscal Dart System	Arthrex GmbH	MAI	Class II	1999-08-13
K982860	Um-L20/ Um-L30	Union Medical Engeneering Co., Ltd.	GEX	Class II	1999-08-13
K992514	Convertors Breathable Surgical Gowns	Medtronic, Inc.	FYA	Class II	1999-08-12
K992499	Gallini Biosystem Bone Marrow Aspiration/biopsy Needle	Gallini U.S., LLC	KNW	Class II	1999-08-12
K992473	Expresseye	Optomotor Laboratories	GWN	Class II	1999-08-12
K992363	Sureskin II Standard, Sureskin II Border, Sureskin II Thin	Euromed, Inc.	FRO	Unclassified	1999-08-12