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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2865 of 3529

510(k) clearances, page 2865 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863734	Steinmann(threaded/calibrated),knowles&hogie Pins	Micro-Aire Surgical Instruments, Inc.	HTY	Class II	1986-10-20
K863666	The Saver Kit	Myocure, Inc.			1986-10-20
K863663	Ophthalmic Surgical Ocular Markers	Myocure, Inc.	HMR	Class I	1986-10-20
K863662	Ophthalmic Surgical Drape	Myocure, Inc.			1986-10-20
K863531	Iq Immunochemistry System	BD Becton Dickinson Vacutainer Systems Preanalytic	JJE	Class I	1986-10-20
K863249	Oxygenator Model No. Bentley-10 Plus	American Bentley	DTZ	Class II	1986-10-20
K862977	Meditrade Artificial Eyes and Implants	Meditrade, Inc.	HPZ	Class II	1986-10-20
K862929	Synectics Motility System	Synectics-Dantec	FFT	Class I	1986-10-20
K862561	Technicon Ra-Xt System with Analytes	Technicon Instruments Corp.	JJC	Class I	1986-10-20
K863754	Foundations Plus Facial-Chin-Neck Supporter 1000	Foundations Plus, Inc.			1986-10-17
K863731	Rotary* Powered Scalpel	Self Sharpening Surgical Steel, Inc.	GEI	Class II	1986-10-17
K863594	Actin Fsl Activated Ptt Reagent	American Dade	GGW	Class II	1986-10-17
K863552	Improved Comspan	Dentsply Intl.	EBF	Class II	1986-10-17
K862948	Chlamydia Tissue Culture Confirmation Test (Eia)	Intercare Diagnostics, Inc.	LJC	Class I	1986-10-17
K862684	Auto-Vac (Tm) Autotransfusion Reserv, Model 7900	Boehringer Laboratories, LLC	CAC	Class II	1986-10-17
K861601	Dp32 Hand Held Dental Prophylaxis Unit	Stewart J. Lustgarten	EIA	Class I	1986-10-17
K860622	Studex Ear Piercing Guns	Onyx Industries, Inc.	JYS	Class I	1986-10-17
K863851	Acid Phosphatase (Acp) Reagent	Sigma Diagnostics, Inc.	CKB	Class II	1986-10-16
K863830	Conseal(tm) Colostomy Continence System	MEDLINE INDUSTRIES, LP - Northfield	EZQ	Class I	1986-10-16
K863679	Allegro Luteinizing Hormone Immunoassay System	Nichols Institute Diagnostics	CEP	Class I	1986-10-16
K863678	Follicle Stimulating Hormone Immunoassay System	Nichols Institute Diagnostics	CGJ	Class I	1986-10-16
K863633	Safety Pins, Elastic Bandages & Stockinettes	Biological & Environmental Control Laboratories	LDQ		1986-10-16
K863631	Sodium Bicarbonate Powder/bicarbonate Hemodialysis	American Healthcare Corp.	KPO	Class II	1986-10-16
K863585	Chloride Procedure	Data Medical Associates, Inc.	CHJ	Class II	1986-10-16
K863566	Gsc 1000	Genetic Systems Corp.	JJQ	Class I	1986-10-16
K863539	Hydro-Clenz Unit	Atlantic Health Group	KPL	Class II	1986-10-16
K862715	Commview System	A T & T Technologies, Inc.	LMD	Class I	1986-10-16
K862631	Bard Iryfix(tm) Stoma Cap	C.R. Bard Inc	EXB	Class I	1986-10-16
K862432	Hepacron Pureair-Zone System	Hepacron, Inc.	FRF	Class II	1986-10-16
K861904	Hs-15M Microwave Surgery Equipment, Microtaze	Cooper Lasersonics, Inc.	KNS	Class II	1986-10-16
K860977	Model 545-45 for Neurological Surgical Application	Britt Corp., Inc.	LLF	Class III	1986-10-16
K860646	Patient Mon 1280/1281/120C/121c & Multi-Para Cart	Analogic Corp.	DPS	Class II	1986-10-16
K852249	Kontron Vitalmon 5010 Patient Monitor	Kontron Instruments, Inc.	BZQ	Class II	1986-10-16
K843511	Bausch & Lomb Cleaning Pad	Bausch & Lomb Incorporated	LPN	Class II	1986-10-16
K863863	Cardionostics Holter Dura-Lite Recorder (Cassette)	Cardionostics, Inc.	DSH	Class II	1986-10-15
K863806	Model a-1 Oxygen Analyzer	Medical, Inc.	CCL	Class II	1986-10-15
K863730	Myolex	Orion Corp.	DDR	Class II	1986-10-15
K863703	Salter Labs Model 4000 Nasal CO2 Sample Line	Salter Labs	CCK	Class II	1986-10-15
K863695	Companion Oxygen Saver	Medtronic, Inc.	NFB	Class II	1986-10-15
K863659	Flow Interruption Indicator	Salter Labs	CCN	Class I	1986-10-15
K863657	Oxygen Conservator	Salter Labs	CCN	Class I	1986-10-15
K863628	C-Reactive Protein (Crp), for Technicon Ra Systems	Technicon Instruments Corp.	DCK	Class II	1986-10-15
K863612	Monaghan Rvm, Model 760 and 761	Monaghan Medical Corp.	BZQ	Class II	1986-10-15
K863556	Csi Liquid Oxygen System	Cryogenic Services, Inc.	BYJ	Class II	1986-10-15
K863177	Cordis Angioplasty Hemostasis Devices	Cordis US Corp.	DTL	Class II	1986-10-15
K863171	Respironics Protecteasy	Respironics, Inc.	KGK	Class I	1986-10-15
K863049	Inhalation Aid	Boehringer Ingelheim Pharmaceuticals, Inc.	BYP	Class I	1986-10-15
K862981	Oticon I31 Initiales Hearing Aid	Oticon, Inc.	ESD	Class I	1986-10-15
K862830	Models 2R and 3R Pneupac Ventilator/resuscitator	Pneupac, Ltd.	BTL	Class II	1986-10-15
K862238	Bivona Fome-Cuf Laser Endotracheal Tube	Bivona Medical Technologies	BTR	Class II	1986-10-15