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 2788 of 3530

510(k) clearances, page 2788 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873335	Wako(tm) Autokit Urea N	FUJIFILM Healthcare Americas Corporation	CDQ	Class II	1987-10-02
K873334	Wako(tm) Autokit Calcium	FUJIFILM Healthcare Americas Corporation	CIC	Class II	1987-10-02
K873333	Wako(tm) Autokit Alp	FUJIFILM Healthcare Americas Corporation	CJE	Class II	1987-10-02
K873329	Hektoen Enteric (He) Agar Product #P3330	Lakewood Biochemical Co., Inc.	JSI	Class I	1987-10-02
K873328	Sabouraud Dextrose - Emmons Agar Plate #P3252	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-10-02
K873327	Sabouraud Dextrose (Sd) Agar, Product #P3330	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-10-02
K873326	Sabouraud Dextrose (Sd) Agar Slant Tube #T3080	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-10-02
K873325	Sabouraud Dextrose Sd Emmons Mod. Agar Slt Tube	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-10-02
K873324	Sabouraud Dextrose (Sd) Broth Tube, #T3331	Lakewood Biochemical Co., Inc.	JSD	Class I	1987-10-02
K873323	Sabouraud Dextrose Sd Agar Slt Tube W/c&c #T4412	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-10-02
K873303	Binax L.s. Tsh Irma Test Kit	Binax, Inc.	JLW	Class II	1987-10-02
K873037	Con-Doa (Tm) Drugs of Abuse Urine Control	Siemens Healthcare Diagnostics Inc.	DIF	Class I	1987-10-02
K872775	Leucoprep Brand Tube	BD Becton Dickinson Vacutainer Systems Preanalytic	JCF	Class I	1987-10-02
K871241	Answer Ovulation Test Kit	Armkel, LLC	CEP	Class I	1987-10-02
K873742	Hood Tracheal & Tracheal-Bronchial Prostheses	Hood Laboratories	NWA	Class II	1987-10-01
K873073	Kirschner Neer-III Proximal Humerus	Kirschner Medical Corp.	HSD	Class II	1987-10-01
K872985	Samuelson Acetabular Cup	Protek, Inc.	KWA	Class III	1987-10-01
K872753	Myostim(tm), Model 6600	Medical Devices Inc.	IPF	Class II	1987-10-01
K872732	Mccutchen Acetabular Cup Prosthesis	Dow Corning Wright	JDI	Class II	1987-10-01
K872578	Mds-90 Argon Dye Laser for Dermatology	Meditec of America	GEX	Class II	1987-10-01
K872517	Tl 400 Totalab Vascular Diagnostic System	D. E. Hokanson, Inc.	JOM	Class II	1987-10-01
K871964	Siegen Neuroscope Seeg for Evoked Response Stimu.	Siegen Corp.	GWF	Class II	1987-10-01
K873744	Leukoclip(r)	Beiersdorf, Inc.	FZQ	Class I	1987-09-30
K873685	Nonprescription Sunglasses	Arcotoys, Inc.	HQY	Class I	1987-09-30
K873608	TENS Lead	Desco Industries, Inc.	GZI	Class II	1987-09-30
K873591	A.r.m. (Aspen Return Monitor)	Qmed, Inc.	GEI	Class II	1987-09-30
K873394	Oval Pull-Apart Sheath/dilator	Quinton, Inc.	DYB	Class II	1987-09-30
K873206	Myocardial Temp. Sensor W/type T Thermocouple	Respiratory Support Products, Inc.	DTW	Class II	1987-09-30
K873178	Ureteral Bulb Dilators	Penn Medical Devices, Inc.	EZN	Class II	1987-09-30
K873157	Oxford Retro-Illumination Cataract Camera	Holofax, Ltd.	HKI	Class II	1987-09-30
K872719	Expanded Use of Hardshell Venous Reserv. W/filter	Shiley, Inc.	DTN	Class II	1987-09-30
K872652	Upgraded Auto Peritoneal Dialysis Cycler System	Travenol Laboratories, S.A.	FKX	Class II	1987-09-30
K872596	Trantec Disposable Pressure Trans.53-600/F/f30	American Edwards Laboratories	DRS	Class II	1987-09-30
K872346	Sure-Strep a Test Kit Catalog No. Mb-1083	Medix Biotech, Inc.	GTZ	Class I	1987-09-30
K872241	Lifescope 12, Bsm 8500A Patient Monitor	Nihon Kohden America Inc	DSI	Class II	1987-09-30
K872166	Facscan Flow Cytometer - Reticcount Reti. Enu. Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	GKL	Class II	1987-09-30
K872068	High Frequency Linear Array (Hfla) Scanhead	Advanced Technology Laboratories, Inc.	DPW	Class II	1987-09-30
K872043	Churchill Inter-Cardiac Sucker	Churchill Corp.	DWF	Class II	1987-09-30
K871727	Modified Radius - Model Number Mm 5000	Ultrasonix, Inc.	JOP	Class II	1987-09-30
K870794	Mem-4104 Evoked Response/electromyography Recorder	Nihon Kohden America Inc	GWL	Class II	1987-09-30
K873681	Alkaline Phosphatase (Alk P) Testpack #67690/95	Em Diagnostic Systems, Inc.	CJE	Class II	1987-09-29
K873678	Spectrophotometer (Microassay Plate Readers)	Slt Labinstruments, Inc.	JJQ	Class I	1987-09-29
K873638	Micro-Chem Analyzer	Ocean Scientific, Inc.	JJQ	Class I	1987-09-29
K873594	Tif Fecal Test	Devetec, Inc.	LEA	Class I	1987-09-29
K873560	U-Impulse Air Conduction in-the-Canal Hearing Aid	Richards Medical Co., Inc.	ESD	Class I	1987-09-29
K873548	Opti-Zyme(r)	Alcon Laboratories	LPN	Class II	1987-09-29
K873515	Uterine Injector 2Mm	Zinnanti Surgical Instruments, Inc.	HES	Class II	1987-09-29
K873468	Custom in-the-Ear Hearing Aid Series Mca20	Maico Hearing Instruments, Inc.	ESD	Class I	1987-09-29
K873467	Quantimetrix Urine Drugs of Abuse Control	Quantimetrix Medical Industries	DIF	Class I	1987-09-29
K873354	Qbc Venous Blood Control/multiple	R & D Systems, Inc.	JPK	Class II	1987-09-29