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 2759 of 3530

510(k) clearances, page 2759 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K874412	The Protector	Tri Jon, Inc.	CAE	Class I	1988-02-12
K873586	Lung Diffusion Gas	National Welders	BXK	Class I	1988-02-12
K872971	Permanent Myocardial Leads Mp Series	Oscor Medical Corp.	DTB	Class III	1988-02-12
K872920	Amici Krypton Administration System*	Amici, Inc.	IYT	Class II	1988-02-12
K872896	Umbilical Artery Oxygen Probe Model Uap-100	American Bentley	CCE	Class II	1988-02-12
K872877	Target Program & Epson Hx-20 Computer	Biomet Microfixation	HAW	Class II	1988-02-12
K872660	Bear Nvm-1	Bear Medical Systems, Inc.	BZK	Class II	1988-02-12
K880278	Malleable PTFE Coated Brain Spatulae	Downs Surgical, Ltd.	HAO	Class I	1988-02-11
K880181	Reganes Disposable Epidural Anesthesia Tray	Reganes, Inc.	CAZ	Class II	1988-02-11
K880089	Finnigan Mat Tsq-70	Finnigan Corp.	DOP	Class I	1988-02-11
K880078	Urea Nitrogen (Bun)	Tech-Neal Scientific, Inc.	CDQ	Class II	1988-02-11
K880069	Leeco Pregnastick (Eia) Catalog #003	Leeco Diagnostics, Inc.	LCX	Class II	1988-02-11
K880032	Medex Machine	Medex, Inc.	ISD	Class II	1988-02-11
K880014	Revisied Labeling for Adx Benzodiazepines	Abbott Medical	JXM	Class II	1988-02-11
K880011	Revised Labeling for Adx Phencyclidine	Abbott Medical	LCL	Unclassified	1988-02-11
K880010	Revised Labeling for Adx Opiates	Abbott Medical	DJG	Class II	1988-02-11
K875196	Disposable Coronary Control Syringe 12Cc	Merit Medical Systems, Inc.	DXT	Class II	1988-02-11
K875148	Medicrat, Hypodermic Syringes & Needles	Knowltech Ind., Inc.	FMF	Class II	1988-02-11
K875081	Immpulse T4 Assay Reagents	Sclavo, Inc.	CDX	Class II	1988-02-11
K875062	Easy-Test Prothrombin Time Pt Item No. 16628	Em Diagnostic Systems, Inc.	GJS	Class II	1988-02-11
K875037	Stryker 1990 Liberty Electric Critical Care Bed	Stryker Corp.	FNL	Class II	1988-02-11
K874918	Iron Procedure	Data Medical Associates, Inc.	JIY	Class I	1988-02-11
K874903	Multichem(r) Y -Glutamyltransferase (Y -Gt)	Simmler Inc	JPZ	Class I	1988-02-11
K874866	T4 Serozyme Enzymeimmunoassay Kit/mag. Solid Phase	Serono Diagnostics, Inc.	KLI	Class II	1988-02-11
K874832	Nova Stat Profile 5 Analyzer + Quality Control	Nova Biomedical Corporation	JGS	Class II	1988-02-11
K874814	Healthdyne Rate Meter	Healthdyne, Inc.	BZQ	Class II	1988-02-11
K874804	Oxygen Supply Control Regulator (Oscr)	Transamerica Products, Inc.	NFB	Class II	1988-02-11
K874782	Coat-a-Count Neonatal 17-Alpha Hydroxprog Ria Kit	Siemens Healthcare Diagnostics Inc.	JLX	Class I	1988-02-11
K874716	Pulsor, Therapeutic Vibrator	Gmg Enterprises, Inc.	ISA	Class I	1988-02-11
K874564	Minimed III Infusion Pump & Uni-Set Admin Set	Medtronic, Inc.	FRN	Class II	1988-02-11
K874498	Csf-Ventriculostomy Reservoir	Pudenz-Schulte Medical Research Corp.	LKG	Class II	1988-02-11
K874496	Calcium Assay Kit, Number 120-19	Diagnostic Chemicals, Ltd. (USA)	CIC	Class II	1988-02-11
K874468	P-S Medical Ventricular Access Port	Pudenz-Schulte Medical Research Corp.	LKG	Class II	1988-02-11
K874451	Omniplane 200 Film Changer System	Medrad, Inc.	IZP	Class II	1988-02-11
K874189	Dual-Cure Radiopaque	Pentron Corp.	EBF	Class II	1988-02-11
K874112	Van-Tec Double Occlusion Balloon Catheter	Van-Tec, Inc.	KOD	Class II	1988-02-11
K874092	Mask, Oxygen	Life Support Products, Inc.	BYG	Class I	1988-02-11
K873557	Mentor Black Light Ureteral Stent Set	Mentor	FAD	Class II	1988-02-11
K873409	Wako(tm) Pretest 6A	FUJIFILM Healthcare Americas Corporation	KHE	Class II	1988-02-11
K873039	Model 820 Top=trak	Sierra Laboratories, Inc.	BYN	Class I	1988-02-11
K880252	Thermal-Pak Model Sw 1000	Micro Tek Engineering	LHC	Class I	1988-02-10
K880244	Surgical Blades	Ailee C/O Havel'S, Inc.	GES	Class I	1988-02-10
K880198	Gemini Surgical Light	American Sterilizer Co.	FSS	Class II	1988-02-10
K880164	RF Card Test & RF Liquid Test	Ampcor, Inc.	DHR	Class II	1988-02-10
K880148	Infectious Mononucleosis (Im) Card & Liquid Test	Ampcor, Inc.	KTN	Class II	1988-02-10
K875356	Immunoglobulin G & G Subclasses	Birmingham	DEW	Class II	1988-02-10
K875283	Qm2/qm300 Control B Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DEM	Class II	1988-02-10
K875281	Qm300 Alpha1-Antitrypsin Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DEM	Class II	1988-02-10
K875246	Lipogen Ana Test Kit	Lipogen, Inc.	LJM	Class II	1988-02-10
K874873	Combigene(tm) Anti-DNA #Kaddz, Kadd1	Siemens Healthcare Diagnostics Inc.	DHN	Class II	1988-02-10