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 2783 of 3530

510(k) clearances, page 2783 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873471	Lmi Cholangiogram Tray	Lazarus Medical Innovations, Inc.	GBZ	Class I	1987-10-23
K873279	8810 Pump-Pump Single Needle Device	Cd Medical, Inc.	FIF	Class II	1987-10-23
K873197	Amk Total Knee System, Patella Component	Depuy, Inc.	JWH	Class II	1987-10-23
K873141	Laser Resistant Drape	Baxter Healthcare Corporation	KKX	Class II	1987-10-23
K873132	Bun Reagent Kit	A-Kem, Inc.	LFP	Class II	1987-10-23
K873131	Creatinine Reagent Kit	A-Kem, Inc.	CGX	Class II	1987-10-23
K873130	Wash Solution Kit	A-Kem, Inc.	JJE	Class I	1987-10-23
K873129	Carbon Dioxide Reagent Kit	A-Kem, Inc.	JFL	Class II	1987-10-23
K873128	Glucose Reagent Kit	A-Kem, Inc.	CGA	Class II	1987-10-23
K873127	Chloride Reagent Kit	A-Kem, Inc.	JFS	Class II	1987-10-23
K873126	Sodium/potassium Reagent Kit	A-Kem, Inc.	JGS	Class II	1987-10-23
K873042	Model 1330 Extension Set	Pharmacia Deltec, Inc.	FPA	Class II	1987-10-23
K872879	Dhea-S Ria Kit	Endocrine Associates, Inc.	JKC	Class I	1987-10-23
K871995	Micros(tm)	Controlled Release Technologies, Inc.	FPA	Class II	1987-10-23
K873931	Modified Models 1025M & 1026T Pacing Lead	Pacesetter Systems	DTB	Class III	1987-10-22
K873873	Resubmitted Micron Transfusion Filter	Travenol Laboratories, S.A.	CAK	Class II	1987-10-22
K872945	Look Fluid Distribution Set	Look, Inc.	FPA	Class II	1987-10-22
K871806	Provider IV. Model 5000 Infusion Device	Pancretec, Inc.	FRN	Class II	1987-10-22
K871529	Tmo-1000, Tmo-3000, Tmo-10,000 Non-Invas. Thermo.	Western Medical Equipment Corp.	FLL	Class II	1987-10-22
K874075	Pt-100-30 Somatosensory Stimulating Electrode	Weaver & Co.	GXY	Class II	1987-10-20
K874054	Fisher Diagnostics Hematall III Las Reagent	Fisher Scientific Company L.L.C.	GGK	Class I	1987-10-20
K873984	Automatic Peritoneal Dialysis Cycler Set (5C4437)	Travenol Laboratories, S.A.	KDJ	Class II	1987-10-20
K873949	Rorertazzi Nasopharyngeal Airway	Penn Medical Devices, Inc.	BTQ	Class I	1987-10-20
K873943	Continuous Epidural Anesth. Kits W/nylon Catheters	Arrow Intl., Inc.	CAZ	Class II	1987-10-20
K873927	Reuseable Breathing Tubes	Dryden Corp.	BZO	Class I	1987-10-20
K873868	Alpha-1-Acid Glycoprotein (Orosomucoid)	Unipath, Ltd.	LKL	Class I	1987-10-20
K873866	Haptoglobin	Unipath, Ltd.	DAD	Class II	1987-10-20
K873862	Albumin in Serum	Unipath, Ltd.	DCF	Class II	1987-10-20
K873814	Ige Immuno Response Test (Irt) Comp. for Mod. Rast	Incstar Corp.	DHB	Class II	1987-10-20
K873800	International Model Xm Behind-the-Ear	Int'L Hearing Aids, Inc.	ESD	Class I	1987-10-20
K873799	International Model Xl Behind-the-Ear	Int'L Hearing Aids, Inc.	ESD	Class I	1987-10-20
K873798	International Model Xp Behind-the-Ear	Int'L Hearing Aids, Inc.	ESD	Class I	1987-10-20
K873770	Bermuda Grass Allergen Disc	Incstar Corp.	DHB	Class II	1987-10-20
K873725	Multichem Creatinine Reagent S0917	Simmler Inc	CGX	Class II	1987-10-20
K873677	Econo-Mist Portable Compressor Driven Nebulizer	Mountain Medical Equipment, Inc.	BTI	Class II	1987-10-20
K873647	Ventrescreen Capillary Blood Collection Tube	Ventrex Laboratories, Inc.	GIO	Class I	1987-10-20
K873642	Osmometer Model 110	Advanced Instruments, LLC	JJM	Class I	1987-10-20
K873625	Chemelia Enzyme Immunoassay for (Tsh)	Boots-Celltech Diagnostics, Inc.	JLM	Class II	1987-10-20
K873623	Aca Urine Barbiturates Screen Method	E.I. Dupont de Nemours & Co., Inc.	DIS	Class II	1987-10-20
K873611	A-Qc Clinical Chemistry Control	Arden Medical Systems, Inc.	JJY	Class I	1987-10-20
K873596	Baker Tdm Theophylline Assay	Baker Instructions Corp.	KLS	Class II	1987-10-20
K873572	Il 35260, Il Test Amylase Reagent	Instrumentation Laboratory Co.	CIJ	Class II	1987-10-20
K873491	Block, Bite, Intubation	B & B Medical Technologies, Inc.	JAY	Class I	1987-10-20
K873431	Progesterone Maia Radioimmuno Assay Kit Mag Sld Ph	Serono Diagnostics, Inc.	JLS	Class I	1987-10-20
K873399	Titan Gel Cpk Rep System	Helena Laboratories, Corp.	JHX	Class II	1987-10-20
K873395	Hoyer Solvet	Infrasonics Corp.	CAF	Class II	1987-10-20
K873386	Titan Gel Ldh Rep System	Helena Laboratories, Corp.	CFE	Class II	1987-10-20
K873369	Securline Franseene Needle	Precision Dynamics Corporation	KNW	Class II	1987-10-20
K873344	Esophageal Stethoscope W/thermistor	Medical Components, Inc.	BZT	Class II	1987-10-20
K873342	Bile Acids Controls	Sigma Diagnostics, Inc.	JJX	Class I	1987-10-20