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 2911 of 3529

510(k) clearances, page 2911 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860367	Magnesium (Substrate, Enzyme, Reagent)	Alpkem Corp.	JGF	Class II	1986-04-11
K860288	Echoclonal Htsh Irma	Bio-Rad	JLW	Class II	1986-04-11
K860090	Answer Plus at Home Pregnancy Test	Armkel, LLC	LCX	Class II	1986-04-11
K860032	Total Ige-Irma Ria Kit	Siemens Healthcare Diagnostics Inc.	DGC	Class II	1986-04-11
K855227	Micro-Eia Theophylline Test Kit Monoclonal	Bioclinical Systems, Inc.	KLS	Class II	1986-04-11
K855146	Laserscope Omniplus Photosurgical Syst/nd:yag Otol	Laserscope	LMS	Class II	1986-04-11
K854622	Prophylactic (Condom)	Medelec Intl. Corp.	HIS	Class II	1986-04-11
K854525	Fox Fastidious Test Panel	Beckman Instruments, Inc.	JWY	Class II	1986-04-11
K854269	Model 509A Physiocorder Ambulatory Recorder	Del Mar Avionics	DSH	Class II	1986-04-11
K854202	Anesthesia Ventilator Model 100	Rusz Instruments, Inc.	CAD	Class II	1986-04-11
K853939	ECG-Electrode(swaromed)	D. Swarovski & Co.	DRX	Class II	1986-04-11
K853051	Tracheal Tubes	Erie Medical	BTO	Class II	1986-04-11
K853039	Pressure Regulator	Erie Medical	CAN	Class I	1986-04-11
K861024	Bard Absorption Dressing	C.R. Bard Inc	FRO	Unclassified	1986-04-10
K860618	Thrust-Aire Model 2001	Charron Industries, Inc.			1986-04-10
K861081	Disposable Hypodermic Needle Safety Sheath	Perkins & Perkins, Inc.	FMI	Class II	1986-04-09
K861065	Ar-1100 Automatic Refractor	Nidek, Inc.	HKO	Class I	1986-04-09
K861054	Disposable Rescue Breathing Device	B & F Medical Products, Inc.	CAE	Class I	1986-04-09
K860961	Gamma Radiation Sterilized Alcohol Prep Pads	H & P Industries, Inc.	LKB	Unclassified	1986-04-09
K860951	Kontron Cutaneous Po2 Monitor 820	Kontron Instruments, Inc.	KLK	Class II	1986-04-09
K860838	Inspiron Double Swivel Trach Adapter	Inspiron Corp.	BZA	Class I	1986-04-09
K860803	IV Filter Extension Set	Med Fusion Systems, Inc.	FPB	Class II	1986-04-09
K860640	Easy-Test (Ggt) Reagent, Item No. 67526/93	Em Diagnostic Systems, Inc.	JQB	Class I	1986-04-09
K860229	Model 900 Infusion Pump	C.R. Bard Inc	FRN	Class II	1986-04-09
K860157	Nitroglycerin Intravascular Administration Set	Quest Medical, Inc	FPA	Class II	1986-04-09
K860099	Medco-Sonic Nq-2000	Medco Products, Co., Inc.	IMI	Class II	1986-04-09
K860042	Nutrimix Empty Container	Abbott Medical	KPE	Class II	1986-04-09
K854866	Long Term Recorder Rag 1200	Nihon Kohden America Inc	DSF	Class I	1986-04-09
K854358	Ez Detech-Urine Blood Test Sticks	Self Care Systems, Inc.	KHE	Class II	1986-04-09
K853663	Accessus Cryopreservation Pkg. Sterile Tissue Stor	Travenol Laboratories, S.A.	LPZ	Unclassified	1986-04-09
K861189	Tecnol Secure-All Fetal Monitor Strap	Tecnol New Jersey Wound Care, Inc.	HGM	Class II	1986-04-08
K861181	Norta Teflon Coated Latex Balloon Catheters	Beiersdorf, Inc.	KOD	Class II	1986-04-08
K860849	Marx Plan, Radiation Therapy Treatment Plan System	Marx Pland	IWB	Class II	1986-04-08
K860810	Medcomp's Femoral Vein Catheters	Medical Components, Inc.	LFK	Class II	1986-04-08
K860796	Dispo-Urette	Roland J. Zwick, Inc.	PCF	Class II	1986-04-08
K860626	Nucor Composite Restorative Material Paste/liquid	Scientific Pharmaceuticals, Inc.	EBF	Class II	1986-04-08
K860620	Shampaine Radi-Op Model 1700Rc	Smith & Nephew, Inc.	KXJ	Class II	1986-04-08
K855098	Compat Enteral Delivery Systems	Sandoz Nutrition	KNT	Class II	1986-04-08
K855097	Compat Enteral Delivery Systems	Sandoz Nutrition	KNT	Class II	1986-04-08
K854773	Supercath A.v. Fistula	Togo Medikit Co., Ltd.	FIE	Class II	1986-04-08
K854389	Nidek US-1600 a-Scan	Nidek, Inc.	IYO	Class II	1986-04-08
K861225	Kodak Automixer II	Eastman Kodak Company	IXW	Class II	1986-04-07
K861106	Fresenius Hemoflow F80 Dialyzer	Seratronics, Inc.	KDI	Class II	1986-04-07
K861087	Avl Model 983 Electrolyte Analyzer	Avl Scientific Corp.	JGS	Class II	1986-04-07
K861080	Cellematics Viral/chlamydal Transport Pack(modifi)	Difco Laboratories, Inc.	JSM	Class I	1986-04-07
K861068	Gilford Uniqual Normal Control Serum - Assayed	Ciba Corning Diagnostics Corp.	JJY	Class I	1986-04-07
K860938	Gambro Fiber Hemofilters Fh 22/66 Dispos Tube Sets	Gambro, Inc.	KDI	Class II	1986-04-07
K860917	Easy-Test Total Protein (Tp), #67513/93	Em Diagnostic Systems, Inc.	CEK	Class II	1986-04-07
K860916	Easy-Test Uric Acid (Uric), #67516/93	Em Diagnostic Systems, Inc.	KNK	Class I	1986-04-07
K860889	Sample Manifold Holder	R. Bell	FMG	Class II	1986-04-07