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 2785 of 3530

510(k) clearances, page 2785 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873750	Labeling Changes Coat-a-Count Methadone in Urine	Siemens Healthcare Diagnostics Inc.	DJR	Class II	1987-10-15
K873712	Standard Knife, Disposable #Tm-1610	Arthropedics, Inc.	HTS	Class I	1987-10-15
K873621	Neer-III Solid Keel Glenoid Resurfacing Prosthesis	Kirschner Medical Corp.	KWT	Class II	1987-10-15
K873620	Neer-III Osteoarthritis Glenoid Resurface Prosthe.	Kirschner Medical Corp.	KWT	Class II	1987-10-15
K873509	Identicult-Bl	Scott Laboratories, Inc.	JTO	Class I	1987-10-15
K873202	Vicor, Model 410A	Tpl-Cordis, Inc.	DXY	Class III	1987-10-15
K873104	Neer-III Glenoid Resurfacing Prosthesis	Kirschner Medical Corp.	KWT	Class II	1987-10-15
K873047	Keane Mobility Bed	Surgi-Med, Inc.	IKZ	Class II	1987-10-15
K872973	W-J Sterile Tri-Functional Contact Lens Solution	Wesley Jessen Corp.	LPN	Class II	1987-10-15
K872949	Acromed Bone Plate Bender	Buckman Co., Inc.	HXW	Class I	1987-10-15
K872858	Williams Vertebral Spreader	Ace Medical	HXP	Class I	1987-10-15
K872846	Nidek Adc-8000 Laser System	Nidek, Inc.	HQF	Class II	1987-10-15
K872770	Dual-Thermistor Thermodilution Cath. & Infu. Cath.	Nova Medical Specialties	DYG	Class II	1987-10-15
K872700	Yhlamydia Cf Antigen and Control Antigen	Sita, Inc.	GPW	Class I	1987-10-15
K872585	Churchill-Cath	Churchill Corp.	FOZ	Class II	1987-10-15
K872247	Fiax Test Kit for Lyme Disease Antibodies	Whittaker Bioproducts, Inc.	LSR	Class II	1987-10-15
K872094	Vacu-Aide	The Devilbiss Co.	JCX	Class II	1987-10-15
K871426	Virogen Hsv Antibody Test	Armkel, LLC	GQO	Class II	1987-10-15
K870395	Churchill Parenteral Nutrition Bag - Eva	Churchill Corp.	KPE	Class II	1987-10-15
K873948	Modified Rectal Nozzle	Colon Therapeutics	KPL	Class II	1987-10-14
K873559	U-Impulse Tvc Air Conduction Hearing Aid	Richards Medical Co., Inc.	ESD	Class I	1987-10-14
K873177	Devine (Suprapubic Sound and Guide)	Penn Medical Devices, Inc.	KOE	Class II	1987-10-14
K873176	Huffman Biopsy Unit	Penn Medical Devices, Inc.	FCL	Class I	1987-10-14
K873147	Usi Dental Polisher. A/g-20	Cranston Ind., Inc.	EFA	Class I	1987-10-14
K872923	Paragon 9000 Tilt and Turn Bed	Surgi-Med, Inc.	FNL	Class II	1987-10-14
K872870	Laser Optical Fibers - Disposable	Optimed Therapeutics	LNK	Class II	1987-10-14
K872824	P. Urine Meter, 250Cc	Ni-Med, Inc.	KNX	Class II	1987-10-14
K872134	Plus Total Knee System, Poly Patellar Button	Orthomet, Inc.	JWH	Class II	1987-10-14
K864963	Stomach Evaculator - Ewald Style	Medovations, Inc.	KOA	Class I	1987-10-14
K873871	Immunoglobulins M	Unipath, Ltd.	DFT	Class II	1987-10-13
K873870	Immunoglobulins G	Unipath, Ltd.	DEW	Class II	1987-10-13
K873869	Immunoglobulins a	Unipath, Ltd.	CZP	Class II	1987-10-13
K873867	Transferrin	Unipath, Ltd.	DDG	Class II	1987-10-13
K873865	Crp	Unipath, Ltd.	DCK	Class II	1987-10-13
K873864	Apolipoprotein B	Unipath, Ltd.	MSJ	Class I	1987-10-13
K873863	Apolipoprotein A1	Unipath, Ltd.	MSJ	Class I	1987-10-13
K873861	Albumin in Urine	Unipath, Ltd.	DCF	Class II	1987-10-13
K873793	Inspirease(r), Drug Delivery System	Key Pharmaceuticals, Inc.	CCQ	Class I	1987-10-13
K873773	Endocoagulator Models 8 and 20 Argon Laser	Hgm, Inc.	GEX	Class II	1987-10-13
K873732	Trach Care Start Kit	Ballard Medical Products	BSY	Class I	1987-10-13
K872876	Imsi/easy Float Mattress	Intl. Management Services, Inc.	FOH	Class I	1987-10-13
K872534	4Lyf Oxygen Concentrator	Airsep Corp.	CAW	Class II	1987-10-13
K872364	Hemodialysis (Sps), Model 550, Code 5M1309	Travenol Laboratories, S.A.	FII	Class II	1987-10-13
K872221	Dialy-Nate Set & Dialy-Nate Catheter	Gesco Intl., Inc.	FKO	Class II	1987-10-13
K872124	Churchill Albumin IV Administration Set	Churchill Corp.	FPA	Class II	1987-10-13
K871931	Istat Software	Neuroscience, Inc.	GWS	Class I	1987-10-13
K871526	Odor-Safe(tm)(liquid) Odor-Safe(tm) Powder	Cox Family Laboratories, Inc.	EXB	Class I	1987-10-13
K873765	Fortec Mi-100, Mi-50 Digital Blood Pressure Meter	Nam Tai, Ltd.	DSK	Class II	1987-10-09
K873687	Angiomat CT Injector	Mallinckrodt Group, Inc.	DXT	Class II	1987-10-09
K873528	Modified Models 253-19 & 254-20 Quantum Generators	Intermedics, Inc.	DXY	Class III	1987-10-09