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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3319 of 3528

510(k) clearances, page 3319 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K803165	Acetabular Cement Compressor	Zimmer GmbH	HXO	Class I	1980-12-31
K803105	Sarns Infant Arterial Bubble Sensor	3M Health Care, Sarns	KPL	Class II	1980-12-31
K803084	Ortho Hematology Control Abnormal Low	Ortho Instruments	JPK	Class II	1980-12-31
K803083	Ortho Hemotology Control-Normal	Ortho Instruments	JPK	Class II	1980-12-31
K803073	Ortho Hematology Control	Ortho Instruments	JPK	Class II	1980-12-31
K803064	Zimmer Electrical Muscle Stimulator	Zimmer GmbH	IPF	Class II	1980-12-31
K803011	Disposable Diaphragm Done	Sorensen Research	DRQ	Class II	1980-12-31
K802961	Transducer Dome, Cat.#sd-101	Sorensen Research	DRQ	Class II	1980-12-31
K802939	Herpes Simplex Type I	Orion Diagnostica, Inc.	GON	Class II	1980-12-31
K802938	Varicella-Zoster Antigens & Controls	Orion Diagnostica, Inc.	GQW	Class II	1980-12-31
K802937	Rubella Virus Antigens & Controls	Orion Diagnostica, Inc.	GON	Class II	1980-12-31
K802936	Respiratory Syncytial Virus Antigen &	Orion Diagnostica, Inc.	GQG	Class I	1980-12-31
K802935	Parainfluenza 1,2, & 3 Antigens & Contr	Orion Diagnostica, Inc.	GQS	Class I	1980-12-31
K802934	Mycoplasma Pneumoniae Antigen & Control	Orion Diagnostica, Inc.	GSB	Class I	1980-12-31
K802933	Mumps S & V Antigens & Controls	Orion Diagnostica, Inc.	GRC	Class I	1980-12-31
K802932	Measles Virus & Controls	Orion Diagnostica, Inc.	GRJ	Class I	1980-12-31
K802929	Adeno Virus & Controls	Orion Diagnostica, Inc.	GOD	Class I	1980-12-31
K802859	Behind-the-Ear Hearing Aid	Danavox, Inc.	ESD	Class I	1980-12-31
K802758	Selective Charcoal Yeast Extract Agar	Remel Co.	JSJ	Class I	1980-12-31
K802750	Nuvox Bedside Tinnitus Masker	Hal-Hen Co., Inc.	KLW	Class II	1980-12-31
K802268	Crc(cyanmethemoglobin Reagent Concent	R & D Systems, Inc.	KHG	Class II	1980-12-31
K802181	Wisconsin Bone Mineral Analyzer	Lunar Radiation Corp.	KGI	Class II	1980-12-31
K802180	Wisconsin Dual-Photon Bone Analyzer	Lunar Radiation Corp.	KGI	Class II	1980-12-31
K801970	Ucla Shoulder	Howmedica Corp.	KWS	Class II	1980-12-31
K803174	Conphar Percussion Hammer(buck Type)	Conphar, Inc.	GWZ	Class I	1980-12-30
K803151	ECG & Ultrasound Gels, Creams & Lotion	Abco Dealers, Inc.	GYB	Class II	1980-12-30
K803121	Mentor 150 Transcutaneous Nerve Stimula	George H. Frisch	GZJ	Class II	1980-12-30
K803119	Large Wound Dressing Kit	American Medical Disposable, Inc.	KDD	Class I	1980-12-30
K803113	Mentor 402 Transcutaneous Elec. Stimulat	George H. Frisch	GZJ	Class II	1980-12-30
K803072	High Frequency Audiometer Delmar #20-K	Demlar Medical, Inc.	EWO	Class II	1980-12-30
K803050	Spray, Synthetic Smear	Laboratory Products, Inc.	IFI	Class I	1980-12-30
K803041	Serum Free Tissue Culture Media	Cartaya Assoc.	KIT	Class I	1980-12-30
K803038	Proximate*ii Disposable Skin Stapler	Ethicon, Inc	GAG	Class II	1980-12-30
K803016	Helena Hemespec II Total Hemoglobin Met.	Helena Laboratories, Corp.	GKR	Class II	1980-12-30
K803015	Hemespec II	Helena Laboratories, Corp.	GKR	Class II	1980-12-30
K803012	Shur-Patch Tape Patch	Shur Medical Corp.	GXY	Class II	1980-12-30
K802992	Elastic Gauze	Abco Dealers, Inc.	FQM	Class I	1980-12-30
K802991	Roll Stretch Gauze	Abco Dealers, Inc.	FQM	Class I	1980-12-30
K802989	Meisinger Tungsten Carbide & Steel Dt.b.	Swiss American Metal Craft Corp.	EJL	Class I	1980-12-30
K802988	Jota Tungsten Carbide & Steel Dent. Burs	Swiss American Metal Craft Corp.	EJL	Class I	1980-12-30
K802987	Jota Diamond Dental Burs	Swiss American Metal Craft Corp.	DZP	Class I	1980-12-30
K802984	Meisinger Diamond Dental Burs	Swiss American Metal Craft Corp.	DZP	Class I	1980-12-30
K802983	The Inquinal Resorvoir Inserter	Lone Star Medical Products	KOA	Class I	1980-12-30
K802967	Dispersalloy-Dispersed Phase Alloy Self-	Johnson & Johnson Professionals, Inc.	DZS	Class I	1980-12-30
K802658	Rodel Electroderm Pads	Rodel Products Corp.	GYB	Class II	1980-12-30
K803117	Custom Dressing Tray Wet to Dry	American Medical Disposable, Inc.	KDD	Class I	1980-12-23
K803118	Simple Dressing Tray #82028	American Medical Disposable, Inc.	KDD	Class I	1980-12-22
K803114	Hyperalimentation Dressing Change Tray	American Medical Disposable, Inc.	FRO	Unclassified	1980-12-22
K803107	Ames Tda Amikacin Control Serum	Miles Laboratories, Inc.	LAS	Class I	1980-12-22
K803102	Arterial Bubble Trap K-20	Delta Medical Industries	KRL	Class II	1980-12-22