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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2533 of 3531

510(k) clearances, page 2533 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K901842	Plastic-Guides	M & K Co.	IWJ	Class I	1990-07-11
K901790	Thermometer, Mercury/clinical	Perlink USA, Inc.	FLK	Class II	1990-07-11
K900865	Add-a-Vial II Binary Connector	Kendall Mcgaw Laboratories, Inc.	LHI	Class II	1990-07-11
K900742	Rate Infuser Plus	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1990-07-11
K900646	Mercury Thermometers (Oral and Rectal)	Abel Industries, Inc.	FLK	Class II	1990-07-11
K900341	Serim Residual Peroxide/renalin Test Kit	Serim Research Corp.	LIF	Class II	1990-07-11
K896197	Colab Cocath(tm) Implanted Catheter and Depot	Colab Intl., Inc.	KXK	Class II	1990-07-11
K895741	Clas Photokeratoscope	Kera-Metrics Corp.	HLQ	Class I	1990-07-11
K902831	Tactylon Tm Surgical Glove	Tactyl Technologies, Inc.	KGO	Class I	1990-07-10
K902753	Imx Ultrasentitive Htsh	Abbott Mfg., Inc.	JLW	Class II	1990-07-10
K902689	Atac 6000 Chemistry Analyzer	Bio-Chem Laboratories	JJE	Class I	1990-07-10
K902635	Modified Granitec P2 & G2 Dental Cements	Confi-Dental Products Co.	EMA	Class II	1990-07-10
K902578	Emit(r) II Calibrator a Level 1 & Level 2	Syva Co.	DKB	Class II	1990-07-10
K902574	Potassium Reagent Set	Tech-Co, Inc.	CEJ	Class II	1990-07-10
K902573	Precipath(r) Im Abnormal Immunassay Control Serum	Boehringer Mannheim Corp.	JJY	Class I	1990-07-10
K902572	Sodium Reagent Set	Tech Intl. Co.	CEI	Class II	1990-07-10
K902567	Staple, Serrated, Fixation W/spikes, Various Sizes	A. Henniss	JDR	Class II	1990-07-10
K902536	Precinorm(r) Im Normal Immunoassay Control Serum	Boehringer Mannheim Corp.	JJY	Class I	1990-07-10
K902483	Creatine Kinase-Mb Test (Mb-Ds) Item #67655	Em Diagnostic Systems, Inc.	CGS	Class II	1990-07-10
K902148	Models 4000,4900,6000,8000,8900,Luxus 60,100,1700	Heraeus Lasersonics, Inc.	GEX	Class II	1990-07-10
K902061	Models 4000,4900,6000,8000,8900,Luxus 60,100&1700	Heraeus Lasersonics, Inc.	GEX	Class II	1990-07-10
K902055	Tenone(tm) Opiates Catalog: Vkso1,4	Siemens Healthcare Diagnostics Inc.	DDE	Class I	1990-07-10
K901995	Pleura Biopsy Device	Mill-Rose Laboratory	GDM	Class I	1990-07-10
K901760	Litter, Folding Rigid Pole, Decontaminable	Dept. of the Army	FPP	Class I	1990-07-10
K901613	Medisense Pen 2/Companion 2 Blood Glucose System	Medisense, Inc.	CGA	Class II	1990-07-10
K901500	Chloride Reagent for the Au5000 Clinical Lab. Ana.	Olympus Corp.	CHJ	Class II	1990-07-10
K901221	Physician Barrier Glove, Surgical	Dynamic Marketing Ent.	LYU	Class I	1990-07-10
K900733	Protein Test for Urine and Csf	Elite Technology, Inc.	CEK	Class II	1990-07-10
K902643	Falcon Disk Drive Subsystem	Sokar, Inc.	JAK	Class II	1990-07-09
K902570	Adam Mark II Custom in-the-Ear Hearing Aid	Adams Hearing Aid Center	ESD	Class I	1990-07-09
K902559	Custom in-the-Ear Hearing Aid Oticon Model: P	Oticon, Inc.	ESD	Class I	1990-07-09
K902237	Medica Iif Anti-Skin Antibody Test Kit	Medica Corp.	DBL	Class II	1990-07-09
K901857	Gadolinium-153 Bone Densitometer (Gdc.10413)	Amersham Corp.	KGI	Class II	1990-07-09
K901854	Gadolinium-153 Bone Densitometer (Gdc.10411/10412)	Amersham Corp.	KGI	Class II	1990-07-09
K901848	Gadolinium-153 Bone Densitometer Sources	Amersham Corp.	KGI	Class II	1990-07-09
K901832	Gadolinium-153 Bone Densitometer Sources Gdc.10415	Amersham Corp.	KGI	Class II	1990-07-09
K901713	Narkomed 4 Anesthesia System	Draeger, Inc.	BSZ	Class II	1990-07-09
K901562	Cvis Insight Imaging Catheter	Cardiovascular Imaging Systems, Inc.	DXK	Class II	1990-07-09
K901262	F.g. Laser (Dental Bur)	Diamond Rotary and Carbide Intl.	DZP	Class I	1990-07-09
K901082	Cyanodont Dental Cement	Specialites Septodont	EMA	Class II	1990-07-09
K900469	Ultrasound Scanner Model #1150	Pie Medical USA BV	IYO	Class II	1990-07-09
K900134	Baby Boards IV Support Assembly	Baby Boards, Inc.	KMK	Class I	1990-07-09
K895909	Sonicaid Model Vasoflo 4	Oxford Medilog, Inc.	MAA	Class II	1990-07-09
K890736	Tfv-2300 Infusion Pump	Nihon Kohden America Inc	FRN	Class II	1990-07-09
K902538	Whiteside Ortholoc Modular Tibial Augmentation	Dow Corning Wright	HRY	Class II	1990-07-06
K902493	Cardiocap II Cg-2Gs, 2G, 1Gs, 1G, 2Cg, Cs Monitor	Datex Division Instrumentarium Corp.	DRI	Class I	1990-07-06
K902492	Cardiocap II Monitors: Ch, Ch-2, Ch-S, Ch-2S	Datex Division Instrumentarium Corp.	DRI	Class I	1990-07-06
K902228	Modified Epicardial Array	C.R. Bard Inc	DRF	Class II	1990-07-06
K902089	Equi-Guard (Aspirator Filter)	Equi-Tron Mfg., Inc.	GCX	Class II	1990-07-06
K901730	Ge Signa Advantage	GE Healthcare	LNH	Class II	1990-07-06