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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3507 of 3526

510(k) clearances, page 3507 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K761251	Weck Tying Forcep, Straight Titanium	Edward Weck, Inc.	HNR	Class I	1976-12-16
K761247	Lt:200, Loving Touch	Litton Dental Products	ELC	Class II	1976-12-16
K761246	Sonus III	Litton Dental Products	ELC	Class II	1976-12-16
K761243	12-9170 Series II Total Hip	Richardo Manufacturing Co.	JDG	Class II	1976-12-16
K761242	Teflon Coated Resectoscope Sheath	V. Mueller O.V. Baxter Healthcare Corp.	FJL	Class II	1976-12-16
K761223	Widex Hearing Aid Model F8	Widex Hearing Aid Co., Inc.	ESD	Class I	1976-12-16
K761222	Benzoin Isobutyl Ether	Solar Laboratories, Inc.			1976-12-16
K761216	Hearing Aids (Model E-552 S-712)	Vicon Instrument Co.	ESD	Class I	1976-12-16
K761215	F4912 Night Vision Aid	Itt Corp.	HPG	Class I	1976-12-16
K761214	Well Counters, Logic II (200 Series)	Abbott Medical	JJJ	Class I	1976-12-16
K761213	Air Enricher	Union Carbide Corp.	CAW	Class II	1976-12-16
K761190	Tracheostomy Care Kit	Superior Plastic Products Corp.	BTO	Class II	1976-12-16
K761163	Ad7 Plastic Multifocal Eyeglass Lens	American Optical Corp.	HQG	Class I	1976-12-16
K761155	Cellulose Eye Stick	Winn Hirsch & Assoc.	HOZ	Class II	1976-12-16
K761150	Gallenaugh Bone Plates	Orthopedic Equipment Co., Inc.	HRS	Class II	1976-12-16
K761146	Sparbaro Type Total Hip	Orthopedic Equipment Co., Inc.	JDG	Class II	1976-12-16
K761145	Radioisotope Calibrator (Crco-22Nb)	G.D. Searle and Co.	KPI	Class II	1976-12-16
K761139	T-M (Time-Motion) Option	G.D. Searle and Co.	HGM	Class II	1976-12-16
K761092	Inguinal Compressive Device (Icd)	Medical Electronic Devices, Inc.			1976-12-16
K761052	Real Time Obstetrical Ultrasonic Scanner	Smithkline Diagnostics, Inc.	HEM	Class II	1976-12-16
K761036	Wilson Spinal Frame	Orthopedic Equipment Co., Inc.	HSQ	Class I	1976-12-16
K761004	X-Ray Scanner, Whole Body, As&e	American Science and Engineering, Inc.	IZF	Class II	1976-12-16
K760910	Disposable K-Pads	Gorman Rupp Industries	ILO	Class II	1976-12-16
K760879	Room Air Purifier (Tex-Dyn)	Texas Dynamics	FRF	Class II	1976-12-16
K760874	v.i. Octoson Ultrasonic System	General Electric Co.	HEM	Class II	1976-12-16
K760696	Remote Control System for Microscope	Alcon Laboratories	EPT	Class I	1976-12-16
K760652	Jesberg Esophagoscopes W/austinetic S S	Pilling Co.	EOX	Class II	1976-12-16
K760522	Table, Urosurgical	Mallinckrodt Group, Inc.	KQS	Class I	1976-12-16
K760469	Cleansing Agent, New Wound (Debrissu)	Pharmaseal Laboratories	KOZ	Class I	1976-12-16
K761228	Luhr Mandibular Compression-Screw System	Howmedica Corp.	DZL	Class II	1976-12-15
K761178	Eto Method - Sterilize Intraocular Lens	Medical Workshop			1976-12-15
K761227	Intermittent Pressure Pad	Flowtron-Aire, Ltd.			1976-12-14
K760714	Endo-Lok L-40 Endocardial Pacing Elect.	Coratomic, Inc.	DTB	Class III	1976-12-14
K761211	Model 15050A Digital Display	Hewlett-Packard Co.	DRT	Class II	1976-12-13
K761206	Interosseous Needle	Smith & Nephew, Mpl Division	DZM	Class I	1976-12-13
K761203	Absorbent Points	Johnson & Johnson Professionals, Inc.	EKN	Class I	1976-12-13
K761196	Nitrous Oxide Scavenging Mask	Mckesson Corp.	CBN	Class II	1976-12-13
K761181	Glucose Oxidase Reagent System	Nobel Scientific Industries, Inc.	CGA	Class II	1976-12-13
K761165	Mt II - Test for Continuous Flow Anal	Technicon Instruments Corp.	JJC	Class I	1976-12-13
K761031	Elecath Arterial Embolectomy Catheter	Electro-Catheter Corp.	DXE	Class II	1976-12-13
K761030	Ekosector I	Smithkline Diagnostics, Inc.	HGM	Class II	1976-12-13
K761168	Max L System	Brinkman Instruments, Inc.	DPM	Class I	1976-12-10
K760944	Angiographic Guidewire	Medrad, Inc.	DQX	Class II	1976-12-10
K761209	Taxo Discs for Diff. of Anaerobes	Bioquest	JTO	Class I	1976-12-09
K761202	Aqua-Seal	Respiratory Care, Inc.	KDQ	Class II	1976-12-09
K761198	Model 3044 3-Channel Stress Test System	Cambridge Instruments, Inc.	DPS	Class II	1976-12-09
K761195	Esophageal Obturation Airway	Mckesson Corp.	CAO	Class II	1976-12-09
K761194	Hlr Quick-Fit Heart-Lung Resuscitator	Mckesson Corp.	DRM	Class II	1976-12-09
K761182	Isotonic Diluent Af	Central Labs. Assoc. MD Pathologists	GGK	Class I	1976-12-09
K761169	Grant Modif of Debakey Abdom Aorta Clmp	Pilling Co.	DXC	Class II	1976-12-09