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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3470 of 3526

510(k) clearances, page 3470 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K771934	Linear Array B-Mode Scanner	G.D. Searle and Co.	IYO	Class II	1977-10-25
K771897	Dinamap Model 837	Applied Medical Research	DXN	Class II	1977-10-25
K771896	Dinamap Model 835	Applied Medical Research	DXN	Class II	1977-10-25
K771895	Dinamap Madel 845	Applied Medical Research	DXN	Class II	1977-10-25
K771873	Vision Series Dental Chair	Chayes Virginia, Inc.	KLC	Class I	1977-10-25
K771872	Martin Lewis Transgrow	Granite Diagnostics, Inc.	JTY	Class II	1977-10-25
K771871	Martin Lewis Agar (Plate)	Granite Diagnostics, Inc.	JTY	Class II	1977-10-25
K771870	Martin Lewis Agar (Jembec)	Granite Diagnostics, Inc.	JTY	Class II	1977-10-25
K771844	Wash Solutions	Gamma Enterprises, Inc.			1977-10-25
K771842	Uric Acid	Gamma Enterprises, Inc.	CDH	Class I	1977-10-25
K771841	Total Protein	Gamma Enterprises, Inc.	CEK	Class II	1977-10-25
K771831	Calcium	Gamma Enterprises, Inc.	CIC	Class II	1977-10-25
K771830	Blood Urea Nitrogen Bun	Gamma Enterprises, Inc.	CDW	Class II	1977-10-25
K771828	Albumin	Gamma Enterprises, Inc.	CIX	Class II	1977-10-25
K771813	Centrifichem Sys 400 Analyzer	Clinical Diagnostics, Inc.	JJG	Class I	1977-10-25
K771804	Aca Ammonia Calibrator	E.I. Dupont de Nemours & Co., Inc.	JIT	Class II	1977-10-25
K771803	Aca Phosphorus Calibrator	E.I. Dupont de Nemours & Co., Inc.	JIT	Class II	1977-10-25
K771802	Aca Iron Calibrator	E.I. Dupont de Nemours & Co., Inc.	JIT	Class II	1977-10-25
K771801	Aca Carbon Dioxide Calibrator	E.I. Dupont de Nemours & Co., Inc.	JIT	Class II	1977-10-25
K771800	Aca Glutamyl Transferase	E.I. Dupont de Nemours & Co., Inc.	JJT	Class I	1977-10-25
K771797	Aca Triglyceride Calibrator	E.I. Dupont de Nemours & Co., Inc.	JIT	Class II	1977-10-25
K771777	Ponceau S Concentrate	Sigma Chemical Co.	HZO	Class I	1977-10-25
K771767	Seralute Tsh (Ria)	Miles Laboratories, Inc.	JLW	Class II	1977-10-25
K771755	9-Way Urine Test with Ascorbic	Miles Laboratories, Inc.	JIL	Class II	1977-10-25
K771731	Cholar Produ&t #17010	Hi Chem, Inc.	CHH	Class I	1977-10-25
K771637	Spectrophotometer Analysis System	Varian Assoc., Inc.	JJQ	Class I	1977-10-25
K771569	Autostreaker	Tomtec			1977-10-25
K771536	Air Vent Filter Needle, 0.45	Jelco Laboratories	FPB	Class II	1977-10-25
K771507	Multistat III Bicarbonate Test	Instrumentation Laboratory Co.	KHS	Class II	1977-10-25
K771496	Chemcode/chemtek System	Boehringer Mannheim Corp.	JJQ	Class I	1977-10-25
K771484	Rinse Block Assem, D-W Peri. Dialysis	Quinton, Inc.	FKX	Class II	1977-10-25
K771421	Catheteo Clamp	Quinton, Inc.	FFN	Class I	1977-10-25
K771352	Electrosurg. Patient Grounding Plate	C.R. Bard Inc	GEI	Class II	1977-10-25
K771073	Gas Chroma. Analysis Sys., Series 37111	Varian Assoc., Inc.			1977-10-25
K771025	Phototherapy/procedure Lamp	Cavitron Corp.	LBI	Class II	1977-10-25
K771971	Hydromassage Equip. Model 1000	Dazey Products Co.	ILJ	Class II	1977-10-21
K771915	Micro Oscillating Saw	American Sterilizer Co.	HTZ	Class I	1977-10-21
K771888	Syringe, Disposable	Orthopedic Equipment Co., Inc.	FMF	Class II	1977-10-21
K771877	Digoxin Ria Kit	Antibodies, Inc.	DNJ	Class II	1977-10-21
K771819	Cabg Rings	A&A Ent.	DSY	Class II	1977-10-21
K771729	17-Hydroxyprogesterone Test Set	Wien Laboratories, Inc.	JLX	Class I	1977-10-21
K771920	Fiber Optics Proctoscope	Propper Mfg Co Inc	GCP	Class II	1977-10-20
K771919	Fiber Optics Sigmoidoscope	Propper Mfg Co Inc	GCP	Class II	1977-10-20
K771918	Fibeo Optics Illum. System	Propper Mfg Co Inc	GCP	Class II	1977-10-20
K771901	Capmix	Espe Dental Products	EFD	Class I	1977-10-20
K771890	Perception Series Delivery Sys.	Chayes Virginia, Inc.	EIA	Class I	1977-10-20
K771889	Uniolite	Espe Dental Products	EBZ	Class II	1977-10-20
K771883	Replica Acid-Etch	Hoyt Laboratories	DYH	Class II	1977-10-20
K771882	Replica Dental Composite-Radiopaque	Hoyt Laboratories	EBF	Class II	1977-10-20
K771880	Replica Dental Composit	Hoyt Laboratories	EBF	Class II	1977-10-20