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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2789 of 3530

510(k) clearances, page 2789 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873350	Easy-Test Emit Procainamide (Proc) #16648	Em Diagnostic Systems, Inc.	LAR	Class II	1987-09-29
K873322	Sabour Dextr Sd Agar Slnt Tube W/chloramp #T3088	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-29
K873321	Sabour Dextrose/bhi Sd/bhi Agar Slt Tube #T4300	Lakewood Biochemical Co., Inc.	KZI	Class I	1987-09-29
K873320	Sabouraud Dextr/bhi Sd/bhi Agar Slt W/6% Sheep Bld	Lakewood Biochemical Co., Inc.	KZI	Class I	1987-09-29
K873319	Sabouraud Dextrose (Sd) W/chloramp Agar Plate	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-29
K873318	Sabour Dextr W/chloramphen/gentam Sd W/c&g Agar Pl	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-29
K873210	Telstar Model Pp	Telstar Electronics, Inc.	ESD	Class I	1987-09-29
K873186	Lh Maiaclone Immunoradio. Assay Kit, Mag Solid Pha	Serono Diagnostics, Inc.	CEP	Class I	1987-09-29
K873171	Stratus(r) Ck-Mb Fluorometric Enzyme Immunoassay	American Dade	JHX	Class II	1987-09-29
K872961	Qtest Strep	Ortho-Clinical Diagnostics, Inc.	GTZ	Class I	1987-09-29
K872852	Eagle Diagnostics Glycohemoglobin Unitized Test	Sandare Chemical Co., Inc.	LCP	Class II	1987-09-29
K872836	Spinoscope	Diagnospine Fabrication, Inc.	IKN	Class II	1987-09-29
K871759	G-Gt Standard Calibrator	FUJIFILM Healthcare Americas Corporation	JIT	Class II	1987-09-29
K871181	Arthrocombi 5003	F.M. Wiest USA, Inc.	HRX	Class II	1987-09-29
K871180	Arthro Automat 5002	F.M. Wiest USA, Inc.	HRX	Class II	1987-09-29
K870967	Adms Transrectal 7.5 Mhz Probe	Diasonics, Inc.	ITX	Class II	1987-09-29
K873691	Cedar(tm) Retractor Ring	Cedar Surgical, Inc.	GZT	Class II	1987-09-28
K873043	Mouth to Face Resuscitator	Artec Environmental Monitoring Division	BTM	Class II	1987-09-28
K872849	Sperm-Select Additional Indication	Pharmacia, Inc.	HDR	Class II	1987-09-28
K872711	Model 20-C W/ar-10A/u Attach. for Arthro. Surgery	Directed Energy, Inc.	GEX	Class II	1987-09-28
K872293	H-H Hunter Active Tendon Implant Bc	Holter-Hausner Intl.	HXA	Class II	1987-09-28
K872285	H-H Hunter Active Tendon Implant Dc	Holter-Hausner Intl.	HXA	Class II	1987-09-28
K872284	H-H Hunter Active Tendon Implant Pc	Holter-Hausner Intl.	HXA	Class II	1987-09-28
K871506	Acuson L538 Transducer	Acuson Computed Sonography	JOP	Class II	1987-09-28
K871416	Auxiliary Continuous Wave Doppler Transducer	Acuson Computed Sonography	JOP	Class II	1987-09-28
K863155	Universal Jet Ventilator Model Ams-1000	Acutronic Medical Systems AG	CBK	Class II	1987-09-28
K873462	Van Dellen Aspirator	Van Dellen, Ltd.	BTA	Class II	1987-09-25
K873430	Fac Ge1/hi Perf Fac Upr Body Te2/full Body Ga 8-12	Klafs Sunlight Corp.	FTC	Class II	1987-09-25
K873400	Prolactin Maiaclone Immunoradio. Kit, Mag Sol Pha	Serono Diagnostics, Inc.	CFT	Class I	1987-09-25
K873170	Aries	Mountain Medical Equipment, Inc.	BYE	Class II	1987-09-25
K873114	Cytomegalovirus Control Slides	Medical Diagnostic Technologies, Inc.	GQH	Class II	1987-09-25
K873035	Vascular Access Port/cath Cat. #Vp-Xxx Vasport Ser	Gish Biomedical, Inc.	DQY	Class II	1987-09-25
K872788	Modified Carotid Shunt W/spring Reinforced Lumen	Uresil, LLC	DWF	Class II	1987-09-25
K872508	Model Micro Fd+ Ambulatory ECG Monitor	Advanced Medical Products, Inc.	DSH	Class II	1987-09-25
K872291	Escort Portable Patient Monitor	Medical Data Electronics	DXO	Class II	1987-09-25
K871970	Double Antibody Ultra-Pth #Kptd1 and Kptd2	Siemens Healthcare Diagnostics Inc.	CEW	Class II	1987-09-25
K871711	Medical Graphics Desktop Diagnostic System	Medical Graphics Corp.	BZM	Class II	1987-09-25
K862970	Temporary Myocardial Pacing Lead, Model 6500	Medtronic, Inc.	LDF	Class II	1987-09-25
K873514	Johnson & Johnson Bipolar Endoprothesis	Johnson & Johnson Professionals, Inc.	KWY	Class II	1987-09-24
K873493	Ninja Scalpel	Primrose Medical, Inc.	GES	Class I	1987-09-24
K873478	Skytron Model 130 Surgical Table	Skytron, LLC	FWY	Class I	1987-09-24
K873290	Laceration and Instrument Trays	Advantage Medical Systems, Inc.	LRP	Class I	1987-09-24
K872937	97-Td Emerson Timer/dimmer Control	J. H. Emerson Co.	IQA	Class II	1987-09-24
K872936	97-D Emerson Dimmer Control	J. H. Emerson Co.	IQA	Class II	1987-09-24
K872911	Cybex 340	Cybex	IKK	Class II	1987-09-24
K872762	Toray Anthron Aorta Bypass Tubes	Toray Industries (America), Inc.	DWF	Class II	1987-09-24
K872710	Model 20-B W/ob-10A/u Attach. for Ear, Nose/throat	Directed Energy, Inc.	EWG	Class II	1987-09-24
K872654	Intelect Model 575	Chattanooga Group, Inc.	IPF	Class II	1987-09-24
K871369	Various Types of: Keeler Magnatone 2 Stethoscopes:	Keeler Instruments, Inc.	LDE	Class I	1987-09-24
K873542	Microplate Auto-Washer (Motorized Stage)	Genetic Systems Corp.	JTC	Class I	1987-09-23