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 1742 of 3531

510(k) clearances, page 1742 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K991686	Latex Examination Gloves, Powder Free with Protein Labeling Claim (50 Mcg or Less)	Arista Latindo Industrial, Ltd. P.T.	LYY	Class I	1999-06-11
K991630	Advanced Medical Solutions-Silicone Gel Scar Management Sheet	Advanced Medical Solutions Group PLC	MDA	Class I	1999-06-11
K991447	Cardioquant Cardiac Assessment Controls	Spectral Diagnostics, Inc.	JJY	Class I	1999-06-11
K991407	Synthes Locking Calcaneal Plates	Synthes (USA) Products LLC	LXT	Class II	1999-06-11
K991215	Symtex Gauze Pads (1'S) and Symtex Gauze Sponges Sterile 2'S and Sterile 10'S	Symtex Healthcare Corp.	EFQ	Unclassified	1999-06-11
K991178	Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac Handpiece, Model 8708.253	Richard Wolf Medical Instruments Corp.	FGB	Class II	1999-06-11
K991143	Magna-Rom 21 Knee Systeem	Sulzer Orthopedics, Inc.	JWH	Class II	1999-06-11
K991002	Psi Titanium Micro-Ligation Hemostatic Clip	V. Mueller Neuro/Spine	FZP	Class II	1999-06-11
K990905	Passy-Muir Low-Profile Tracheostomy Speaking Valve Pmv 2020 (Clear) Jit	Passy-Muir, Inc.	JOH	Class II	1999-06-11
K990864	Speedband Superview Multiple Band Ligator, Models 4225, 4228	Boston Scientific Corporation	MND	Class II	1999-06-11
K990852	Coopersurgical Infrared Coagulator	CooperSurgical, Inc.	KNS	Class II	1999-06-11
K990183	Implex Alumina Femoral Head	Implex Corp.	LZO	Class II	1999-06-11
K983791	Peripheral Retrograde Cardiaplegia Cannula	Edwards Lifesciences LLC	DWF	Class II	1999-06-11
K982448	Cardiolight	Mirion Technologies (Capintec), Inc.	DSH	Class II	1999-06-11
K991467	K-Assay Rheumatoid Factor Calibrator Set	Kamiya Biomedical Company, LLC	DHR	Class II	1999-06-10
K991418	Browne Mvi Ethylene Oxide Indicator	Sybron Dental Specialties, Inc.	JOJ	Class II	1999-06-10
K991166	K-Assay Microalbumin Calibrator Set	Kamiya Biomedical Company, LLC	JIX	Class II	1999-06-10
K991127	Variant II B-Thalassemia	Bio-Rad	JPD	Class II	1999-06-10
K991113	`Inear Wrist Coil, Model 440Ge-09	Medical Advances, Inc.	MOS	Class II	1999-06-10
K991099	American Dental Products Etch-Detect	American Dental Products, Inc.	EBC	Class II	1999-06-10
K990920	Drg Titanium Bone Plate	Doctor'S Research Group, Inc.	JEY	Class II	1999-06-10
K990871	Pillowpositive Cervical Pillow	Lifesleep Systems, Inc.	MYB	Class II	1999-06-10
K990846	Amorphous Diamond Coated Drill	Nobel Biocare Uas, Inc.	DZI	Class II	1999-06-10
K990246	Steri-Pak Lf Bowie-Dick Test Pack	Steritec Products Mfg. Co., Inc.	JOJ	Class II	1999-06-10
K980438	11.5F X 6 (15Cm) Duo-Split Catheter Mcds116mt, 11.5F X 8 (20Cm) Duo-Split Catheter Mcds118mt	Medical Components, Inc.	MPB	Class II	1999-06-10
K991797	Immulite Turbo Ck-Mb, Models Lskcp1, Lskcp5	Siemens Healthcare Diagnostics Inc.	JHX	Class II	1999-06-09
K991796	Immulite Turbo Myoglobin, Models Lskmy1, Lskmy5	Siemens Healthcare Diagnostics Inc.	DDR	Class II	1999-06-09
K991795	Immulite Turbo Troponin I, Models Lskti1, Lskti5	Siemens Healthcare Diagnostics Inc.	MMI	Class II	1999-06-09
K991734	Modification of: Hermes Operating Room Control Center	Computer Motion, Inc.	GCJ	Class II	1999-06-09
K991619	FOUNTAIN Infusion Catheter and Occluding Guide Wire	Merit Medical Systems, Inc.	QEY	Class II	1999-06-09
K991611	Ge Logiq 500	General Electric Co.	IYO	Class II	1999-06-09
K991604	Epi-Foam Silicone Sheeting	Biodermis LLC	MDA	Class I	1999-06-09
K991600	Somatom Plus 4 with Sliding Gantry Option	Siemens Corp.	JAK	Class II	1999-06-09
K991410	3402 Handheld Pulse Oximeter	Bci Intl., Inc.	DQA	Class II	1999-06-09
K991409	K-Assay Rheumatoid Factor	Kamiya Biomedical Company, LLC	DHR	Class II	1999-06-09
K991301	Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-on Anti-Siphon Valve, Cadd Administration Set with 1	Sims Deltec, Inc.	FPA	Class II	1999-06-09
K991255	Cadd-Tpn Administration Set, Model 21-7071	Sims Deltec, Inc.	FPA	Class II	1999-06-09
K991183	Dornier Lasertrode Fiber	Dornier Surgical Products, Inc.	GEX	Class II	1999-06-09
K991106	P.f.c. Sigma Porous Modular Keel Tibial Tray	Depuy Orthopaedics Inc.	JWH	Class II	1999-06-09
K991102	Copilot Bleedback Control Valve, Model 1003331	Boston Scientific Corporation	DTL	Class II	1999-06-09
K991086	Capnocheck II, Model 8400	Bci Intl., Inc.	CCK	Class II	1999-06-09
K991077	Microelectroencephalography Professional System 5000 (EEG Pro System 5000)	Microrecording Systems Consultants, LLC	GZL	Class II	1999-06-09
K991003	Pump Segment Rinse Line W/ Slip-on Connector, Pump Segment Rinse Line W/ Luer-Lock Connector, T-Connector, Short, W/ Sli	Dayspring Medical, Inc.	FKY	Class II	1999-06-09
K990974	Vitop Dressing	Wonder & Bioenergy Hi-Tech America, Inc.	EFQ	Unclassified	1999-06-09
K990954	Elec-Mate, Models Ex-6 Set, Ex-6L Set, Ex-30 Set	Nsk Nakanishi, Inc.	EBW	Class I	1999-06-09
K990912	Mtp Extraction Bag	Mtp Medical Technical Promotion GmbH	GCJ	Class II	1999-06-09
K990909	Mtp Uropump Disposable Tubing Set	Mtp Medical Technical Promotion GmbH	LJH	Class II	1999-06-09
K990809	Cadiscope Electronic Stethoscope	Caditec AG	DQD	Class II	1999-06-09
K990243	Fotona Fidelis Er:yag Laser System & Accessories	Fotona D.D.	GEX	Class II	1999-06-09
K990063	Nihon Kohden Tg-901T CO2 Sensor Kit with Accessories	Nihon Kohden America Inc	CCK	Class II	1999-06-09