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 2769 of 3530

510(k) clearances, page 2769 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K874403	A Series of 7 Inch Continuous Infusion Sets	Quinton, Inc.	FPA	Class II	1987-12-29
K874380	Bte Hearing Aid Oticon Model E38p	Oticon, Inc.	ESD	Class I	1987-12-29
K874335	Explorer-Dental Prober	Military Engineering, Inc.	EKJ	Class I	1987-12-29
K874312	Ackrad Retrograde Urethrography Set	Ackrad Laboratories	KOD	Class II	1987-12-29
K874294	Autochuck Attachment	Den-Tal-Ez Mfg Co., Inc.	EFB	Class I	1987-12-29
K874293	Ackrad V/cug Voiding Cystourethrography Set	Ackrad Laboratories	KOD	Class II	1987-12-29
K874239	Cleaning Brush	Endovations	MNL	Class I	1987-12-29
K874227	Plastic Brackets	Advanced Orthodontics Systems, Inc.	DYW	Class II	1987-12-29
K874226	Standard Edgewise/all Systems Go/ultra Low Bracket	Advanced Orthodontics Systems, Inc.	EJF	Class I	1987-12-29
K874208	Bard Octapolar Electrode Catheter	C.R. Bard Inc	DRF	Class II	1987-12-29
K874186	Bowl, Sponge, Disposable, Sterile & Non-Sterile	Busse Hospital Disposables	LDQ		1987-12-29
K874158	Ccs Implantable Maestro(r) Series 100/200 Pacemak.	Cardiac Control Systems, Inc.	DXY	Class III	1987-12-29
K874151	RF Dipstick Test Kit	Lipogen, Inc.	DHR	Class II	1987-12-29
K874074	Temporary Disclosing Solution	Dentsply Intl.	KLE	Class II	1987-12-29
K874016	Oval Cup Biopsy Forcep(23/5) Used W/gastro/sigoido	Endovations	OCZ	Class II	1987-12-29
K874015	Hollow Alligator Grasping Forcep (Model 23/12)	Endovations	OCZ	Class II	1987-12-29
K874014	Oval Cup with Needle Biopsy Forcep (Model 23/1)	Endovations	OCZ	Class II	1987-12-29
K874013	Oval Cup Biopsy Forcep(23/5) Used W/colonoscope	Endovations	OCZ	Class II	1987-12-29
K874012	Oval Cup Biopsy Forcep (Model 18/5)	Endovations	OCZ	Class II	1987-12-29
K874011	Oval Cup with Needle Biopsy Forcep (Model 23/1)	Endovations	OCZ	Class II	1987-12-29
K874010	Round Cup Hot Biopsy Forcep (Model D-52)	Endovations	OCZ	Class II	1987-12-29
K874009	Oval Cup Hot Biopsy Forcep (Model C-52)	Endovations	OCZ	Class II	1987-12-29
K874008	Oval Cup Hot Biopsy Forcep (Model B-51)	Endovations	OCZ	Class II	1987-12-29
K874007	Oval Cup Hot Biopsy Forcep (Model a-51)	Endovations	OCZ	Class II	1987-12-29
K874006	Grasping Tripod Forcep (Model 23/25)	Endovations	OCZ	Class II	1987-12-29
K874005	Rat Tooth Grasping Forcep (Model 23/20)	Endovations	OCZ	Class II	1987-12-29
K874004	Alligator Jaw Grasping Forcep (Model 23/125)	Endovations	OCZ	Class II	1987-12-29
K874003	Hollow Alligator Grasping Forcep (Model 18/12)	Endovations	OCZ	Class II	1987-12-29
K873996	Carey Capsule	Wilson-Cook Medical Inc.	KNW	Class II	1987-12-29
K873961	Infumed 300 Ambulatory Infusion Pump	Med Fusion Systems, Inc.	FRN	Class II	1987-12-29
K873920	Br-2 Biorest	Biorest, Inc.	QJQ	Class II	1987-12-29
K873907	Confirmation Tests	Richmond Products, Inc.	HPC	Class I	1987-12-29
K873859	Cardiocap(tm) Pulse Oximetry Module Cos-104	Datex Division Instrumentarium Corp.	DQA	Class II	1987-12-29
K873729	Rate-Mate Nitroglycerin i.v. Administration Set	Critikon Company, LLC	FPA	Class II	1987-12-29
K873682	Ferris ECG Electrode W/hydrogel	Ferris Mfg. Corp.	DRX	Class II	1987-12-29
K873643	Gambro Adsorba 150C	Gambro, Inc.	FLD	Class II	1987-12-29
K873522	Bard Ambulatory Pca Drug Delivery System	C.R. Bard Inc	FRN	Class II	1987-12-29
K873489	Emerson Dispos Thoracic Drainage Set - 551-8000	J. H. Emerson Co.	GCX	Class II	1987-12-29
K873356	Insure Porcelain Veneer Bonding System	Cosmedent, Inc.	EMA	Class II	1987-12-29
K872781	Easi Lead System Cable Assembly	Totemite Medical Electronics	DRW	Class II	1987-12-29
K872767	Filtral 10, Filtral 12, Filtral 16 Hemodialyzer	Hospal Medical Corp.	KDI	Class II	1987-12-29
K872565	Duoflo Dispenser	Hemaedics, Inc.	FMF	Class II	1987-12-29
K872528	Omnifit Distal Stem Cement Spacers	Osteonics Corp.	JDK	Class II	1987-12-29
K872294	Combination Nite Drainage Unit	Arnold Technologies	EXB	Class I	1987-12-29
K871751	Quik-Pace Noninvasive Pacemaker	Physio Control, Inc.	DRO	Class II	1987-12-29
K874963	Manual Ophthalmic Surgical Instruments	Solway, Inc.	HNA	Class I	1987-12-23
K874900	Woodlyn Classic Refractor, Phoroptor	Woodlyn, Inc.	HKN	Class I	1987-12-23
K874865	Damon D.e.t.e.c.t Image Enhancer	Damon Corp.	LLZ	Class II	1987-12-23
K874845	Malis Surgical Loupes	Valley Forge Scientific Corp.	HJH	Class I	1987-12-23
K874630	Range of Titanium Neurosurgery Instruments	Downs Surgical, Ltd.	HAO	Class I	1987-12-23