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 2724 of 3530

510(k) clearances, page 2724 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882349	Mallet, Surgical	Treace Medical, Inc.	HXL	Class I	1988-06-23
K882333	Floor Light	Commercial Products & Engineering Co.	FSS	Class II	1988-06-23
K882309	The Direction Dial	Lawhorn Innovations	EKJ	Class I	1988-06-23
K882284	Surgeons Cap	A Plus International, Inc	FYF	Class I	1988-06-23
K882283	Bouffant Cap	A Plus International, Inc	FYF	Class I	1988-06-23
K882282	Suit, Surgical	A Plus International, Inc	FXO	Class I	1988-06-23
K882281	Gown, Isolation, Surgical (Fyc)	A Plus International, Inc	FYC	Class II	1988-06-23
K882280	Cover, Shoe Operating Room	A Plus International, Inc	FXP	Class I	1988-06-23
K882269	Storz Diagnostic Microscope System	Storz Instrument Co.	EPT	Class I	1988-06-23
K882244	Richards Thermoplastic Dorsal Nasal Splint	Richards Medical Co., Inc.	EPP	Class I	1988-06-23
K881743	Vas-Cath Flexxicon Dual Lumen Dialysis Catheter	Vas-Cath, Inc.	LFJ	Class II	1988-06-23
K881695	Deseret Subclavian Hemodialysis Catheter	Deseret Medical, Inc.	LFJ	Class II	1988-06-23
K881686	CPR Bag	Devolve Corp.	BTM	Class II	1988-06-23
K881363	Syringe Prefilled with Water	I M, Inc.	KOD	Class II	1988-06-23
K880386	Kimberly-Clark Protective Sleeve	Kimberly-Clark Corporation	FYA	Class II	1988-06-23
K880384	Kimberly-Clark X-Tra Traction Impervious Boot	Kimberly-Clark Corporation	BWP	Class I	1988-06-23
K880383	Kimberly-Clark Full Length Heavy Duty Apron	Kimberly-Clark Corporation	FYA	Class II	1988-06-23
K880382	Kimberly-Clark Impervious Open Back Gown	Kimberly-Clark Corporation	FYA	Class II	1988-06-23
K875052	Tdp, Lark Brand and Mit Lamp	I.E.C. Co.	ILY	Class II	1988-06-23
K874615	Laser Cannister Filter	Medical Marketing, Inc.	HHR	Class II	1988-06-23
K874614	Suction and Lavage Probe	Medical Marketing, Inc.	HET	Class II	1988-06-23
K874612	Titanium Rods	Medical Marketing, Inc.	HET	Class II	1988-06-23
K874611	Titanium Backstop with Suction	Medical Marketing, Inc.	HET	Class II	1988-06-23
K874211	Eub-450 Diagnostic Ultrasound Device	Hitachi Medical Corp. of America	IYO	Class II	1988-06-23
K882463	Potato Dextrose Agar (Pda) - Product #P3421	Lakewood Biochemical Co., Inc.	JSJ	Class I	1988-06-22
K882362	Stat Fix Microwave Irradiation Medium	Stat Path	LDJ	Class II	1988-06-22
K882331	Shaw Sun Systems Model 1600	Shaw Sun Systems	LEJ	Class II	1988-06-22
K882277	Abbott Testpack(tm) Rsv Positive Control	Abbott Medical	GQG	Class I	1988-06-22
K882185	Electronic Insufflator, Model No. 2054.60	Richard Wolf Medical Instruments Corp.	HIF	Class II	1988-06-22
K882160	Coherent System 920 Argon/dye Photocoagulator	Coherent Medical Lasers	GEX	Class II	1988-06-22
K882139	2P-Qda Foot Pressure Systems Real Time	Human Performance Technologies, Inc.	JFC	Class I	1988-06-22
K882135	Aqua Dent Handpiece Extension and Aqua Dent Disp.	Vita Dental Co.	EFB	Class I	1988-06-22
K881935	Microcirrus Medical Nebulizer	Dhd Medical Products Div. Diemolding Corp.	CAF	Class II	1988-06-22
K881902	Healthtronic Omega Trac	Healthtronics Surgical Services, Inc.	JFB	Class II	1988-06-22
K881769	Hjd Calcar Replacement Prosthesis	Richards Medical Co., Inc.	JDI	Class II	1988-06-22
K881504	Ven-a-Cath Percutaneous Venous Catheter Kit	Hdc Corp.	DQY	Class II	1988-06-22
K881447	Metatech Metal Microclip	Metatech Corp.	DXC	Class II	1988-06-22
K881403	Mccain Monopolar & Bipolar Cautery	Biomet Microfixation	GEI	Class II	1988-06-22
K881322	Mini-Temp(tm)	Seabrook Medical Systems, Inc.	DWJ	Class II	1988-06-22
K881272	Accustat Model 102 Non-Invasive Blood Monitoring	Accustat, Inc.	DXN	Class II	1988-06-22
K881039	Hydrocolloid Dressing for Psoriasis	Hollister, Inc.	FRO	Unclassified	1988-06-22
K875216	High Performance Calibrators	Rapid Diagnostic Laboratories, Inc.	DKB	Class II	1988-06-22
K882399	Aseptip	Koppa Innovative Dental Products, Inc.	EKJ	Class I	1988-06-21
K882292	Sullivan Nasal CPAP System	Baxter Centre for Medical Research	BYE	Class II	1988-06-21
K882210	Mediblend (Tm) Lung Diffusion Gas Mixtures	Linde Div. Union Carbide Corp.	BXK	Class I	1988-06-21
K882183	Dental Burs	Tri-Stage, Inc.	EJL	Class I	1988-06-21
K881790	Safety Drain	Ballard Medical Products	BYH	Class I	1988-06-21
K881630	Automatic Caloric Irrigation System	Ics Medical Corp.	KHH	Class I	1988-06-21
K881625	Conchatherm III Plus Dual Heat Wire Servo Controll	Respiratory Care, Inc.	BZE	Class II	1988-06-21
K881605	Biopsy Guide	Teknar, Inc.	IYO	Class II	1988-06-21