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 2708 of 3530

510(k) clearances, page 2708 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882347	Harmac Extension Infusion Set	Harmac Medical Specialties, Inc.	FPA	Class II	1988-08-30
K882338	Model #716 Adult Stim. Pads Low Impedance Gel Type	Cardiotronics, Inc.	DRO	Class II	1988-08-30
K882321	Acs Deflectable Tip Guide Wire W/microglide(r)coat	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1988-08-30
K882258	Dc-Liquical Catalogue #Se-030	Diagnostic Chemicals, Ltd. (USA)	JIX	Class II	1988-08-30
K882219	p.e.e.p. Valve	Life Support Products, Inc.	BYE	Class II	1988-08-30
K881753	Alpha-Stim 350	Electromedical Products, Inc.	GZJ	Class II	1988-08-30
K881750	Normal Humeral Prosthesis	Osteonics Corp.	KWS	Class II	1988-08-30
K881715	28200 Series Micro-Arthro. Sterile Disp. Blades	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1988-08-30
K881494	Four Modifications to Ophthalas Argon/dye Laser	Biophysic Medical, Inc.	HQF	Class II	1988-08-30
K880971	Digital Medicine ECG Monitor and Recorder	Digital Medicine Systems	DXH	Class II	1988-08-30
K880886	Ebv-Vca Igm Antibody Test System (Fluorescent)	IMMUNO CONCEPTS, NA, Ltd.	LJN	Class I	1988-08-30
K880885	Ebv-Vca Igg Antibody Test System (Enzyme)	IMMUNO CONCEPTS, NA, Ltd.	GNP	Class I	1988-08-30
K880884	Ebv-Vca Igm Antibody Test System (Enzyme)	IMMUNO CONCEPTS, NA, Ltd.	LJN	Class I	1988-08-30
K880883	Ebv-Vca Igg Antibody Test System (Fluorescent)	IMMUNO CONCEPTS, NA, Ltd.	GNP	Class I	1988-08-30
K875203	Du Pont Ebna-Igg Antibody Elisa Kit	E.I. Dupont de Nemours & Co., Inc.	LLM	Class I	1988-08-30
K883514	Exakt Cutting & Grinding System	Exakt Medical Instruments, Inc.	IDP	Class I	1988-08-29
K883502	Fetal Bovine Serum, Defined No. 110-1121	J R Scientific	KIT	Class I	1988-08-29
K883501	Mccoy's 5A Medium (Catalog No. 210-3531)	J R Scientific	KIT	Class I	1988-08-29
K883500	Mccoy's 5A Medium 10X No. 210-3532	J R Scientific	KIT	Class I	1988-08-29
K883499	Medium 199, 10X, Catalog No. 210-3557	J R Scientific	KIT	Class I	1988-08-29
K883498	Fetal Bovine Serum, Heat Inactivated No.110-1123	J R Scientific	KIT	Class I	1988-08-29
K883497	Medium 199, 10X Catalog No. 210-3556	J R Scientific	KIT	Class I	1988-08-29
K883496	Minimum Essential Medium Eagle (Mem), 210-3517	J R Scientific	KIT	Class I	1988-08-29
K883495	Medium 199, 10X, Catalog No. 210-3555	J R Scientific	KIT	Class I	1988-08-29
K883450	Sfre 199-2 Medium, Catalog No. 200-2192	J R Scientific	KIT	Class I	1988-08-29
K883449	Minimum Essential Medium Eagle, No. 200-2048	J R Scientific	KIT	Class I	1988-08-29
K883448	Minimum Essential Medium Eagle No. 200-2046	J R Scientific	KIT	Class I	1988-08-29
K883447	Minimum Essential Medium Eagle 10X, No.210-3511	J R Scientific	KIT	Class I	1988-08-29
K883446	Fetal Bovine Serum, Gamma Irradiated No. 110-1122	J R Scientific	KIT	Class I	1988-08-29
K883445	Hanks' Balanced Salts (Hbss) 10X, No. 210-3012	J R Scientific	KIT	Class I	1988-08-29
K883370	Fischer's Medium Catalog No. 210-4007	J R Scientific	KIT	Class I	1988-08-29
K883369	L-15 Medium, Catalog No. 210-4004	J R Scientific	KIT	Class I	1988-08-29
K883368	Newborn Calf Serum, Catalog No. 110-1130	J R Scientific	KIT	Class I	1988-08-29
K883367	Calf Serum, Catalog No. 110-1125	J R Scientific	KIT	Class I	1988-08-29
K883366	Medium 199, Catalog No. 200-2031	J R Scientific	KIT	Class I	1988-08-29
K883365	Horse Serum, Abattoir, No. 110-1112	J R Scientific	KIT	Class I	1988-08-29
K883364	Iscove's Modified Delbecco's Medium No.210-3505	J R Scientific	KIT	Class I	1988-08-29
K883363	Iscove's Modified Delbecco's Medium No.200-2105	J R Scientific	KIT	Class I	1988-08-29
K883362	L-15 Medium, Catalog No. 200-2021	J R Scientific	KIT	Class I	1988-08-29
K883115	Pmt Subarachnoid Screw, Model No.1350-2	PMT Corp.	GWM	Class II	1988-08-29
K882961	Emit Qst Carbamazepine Assay	Syva Co.	KLT	Class II	1988-08-29
K882909	Sceptor - New Antimicrobial Agent: Rifampin	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-08-29
K882820	Medipac II Ec (Tm), Model 7900	Medical Devices Inc.	GZJ	Class II	1988-08-29
K882801	Rinse & Reference Solution/buffer/low & High Stan.	Hf Scientific, Inc.	JGS	Class II	1988-08-29
K882795	Dade(r) Ck-Mb Immunoassay Control	Baxter Healthcare Corporation	JJT	Class I	1988-08-29
K882726	Raichem(tm) Bilirubin Standard	Reagents Applications, Inc.	JIS	Class II	1988-08-29
K882676	Pharmacia Chlamydia Eia	Pharmacia, Inc.	LJC	Class I	1988-08-29
K882608	Lad Model 633 Luminometer	Los Alamos Diagnostics	JJQ	Class I	1988-08-29
K882593	Modified Continuous Cardiac Output Monitor System	Cardio Metrics, Inc.	DPW	Class II	1988-08-29
K882468	Eliminator Air Filter	Apex Medical, Inc.	KDQ	Class II	1988-08-29