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 2489 of 3531

510(k) clearances, page 2489 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K904034	Temporary Dental Cement	Medical Device Inspection Company	EMA	Class II	1990-12-27
K903580	Micro-Mister	Bp, Ltd.	CAF	Class II	1990-12-27
K903376	Acromed Sacral Screw	Acromed Corp.	KWP	Class II	1990-12-27
K903113	Cga-112 Coping Gold Alloy	Minimatic Implant Technology	DZE	Class II	1990-12-27
K903083	Neonatal Ventilator Circuit	Hudson Respiratory Care, Inc.	BZO	Class I	1990-12-27
K896903	First Medic Model 510	Spacelabs, Inc.	LDD	Class II	1990-12-27
K905622	Coulter Direct Billrubin Reagent	Coulter Electronics, Inc.	CIG	Class II	1990-12-26
K905521	Cedia(r) Theophylline Assay/modification	Microgenics Corporation	LER	Class II	1990-12-26
K905389	Chem-Chex Lipid	Streck Laboratories, Inc.	JJY	Class I	1990-12-26
K905296	Cholestech Lipid Monitoring System,hdl Cholesterol	Cholestech Corp.	LBS	Class I	1990-12-26
K905222	Cedars-Sinai Quantitative Ti-201 Analysis Ctq 2.0	Nuccardiac Software, Inc.	LLZ	Class II	1990-12-26
K904814	Glyc-Affin Gp	Isolab, Inc.	LCP	Class II	1990-12-26
K904767	Acs Cholestrerol/triglyceride Liquid Linear Calibr	Analytical Control Systems	JIX	Class II	1990-12-26
K904612	I/a-Phaco System (Irr./aspir./and Phaco./system)	Medical Technical Products, Inc	HQC	Class II	1990-12-26
K904571	Emit(r) II Cannabinoid 50 Ng Assay	Syva Co.	LDJ	Class II	1990-12-26
K904570	Emit(r) II Cannabinoid 20 Ng Assay	Syva Co.	LDJ	Class II	1990-12-26
K904569	Emit(r) II 9 Cannabinoid Negative Calibra/controls	Syva Co.	DLJ	Class II	1990-12-26
K904568	Emit(r) II Cannabinoid 100 Ng Assay	Syva Co.	LDJ	Class II	1990-12-26
K904524	Captia(r) Syphilis M, Modification	Mercia Diagnostics, Ltd.	LIP	Class II	1990-12-26
K904082	Cholestech Lipid Monitoring System, Glucose Test	Cholestech Corp.	CGA	Class II	1990-12-26
K904081	Glucometer Qa Blood Glucose Meter and Glucofilm	Kulzer GmbH	CGA	Class II	1990-12-26
K903965	Statpal Blood Gas Monitoring System	Ppg Industries, Inc.	CHL	Class II	1990-12-26
K903126	Cholestat(tm) Whole Blood Cholesterol Test	Crystal Diagnostics, Inc.	CHH	Class I	1990-12-26
K903039	A-1101 Cast Abutment	Minimatic Implant Technology	DZE	Class II	1990-12-26
K902987	G.e. Dxs 350/550/650/650Ii Single Phase Generators	Electromek Diagnostic Systems, Inc.	IZO	Class I	1990-12-26
K895965	Dcl - Syphilis-G Assay Catalog No. 600-70	Diagnostic Chemicals, Ltd. (USA)	LIP	Class II	1990-12-26
K905330	Harmony Line Alloys	Ivoclar North America, Inc.	EJT	Class II	1990-12-24
K905326	Minigold	Ivoclar North America, Inc.	EJT	Class II	1990-12-24
K905324	Will-Ceram W-1	Ivoclar North America, Inc.	EJT	Class II	1990-12-24
K905323	Will-Ceram Y and Will -Ceram Y-1	Ivoclar North America, Inc.	EJT	Class II	1990-12-24
K905029	Model 2001, Modification	Medfusion, Inc.	FRN	Class II	1990-12-24
K904906	Sharpoint Polypropylene Nonabsorb Surg Sutures Usp	Chathamborough Research Group, Inc.	GAW	Class II	1990-12-24
K904588	Auto Suture(r) Modified Endoscopic Ligating Loop	United States Surgical, A Division of Tyco Healthc	GAL	Class II	1990-12-24
K904470	Summit Tech 19/20 Gauge Ophthalmic Fiberendoscope	Summit Technology, Inc.	EQH	Class I	1990-12-24
K904428	Panosol II Uab-228	National Biological Corp.	FTC	Class II	1990-12-24
K904427	Panosol II Uvb-206	National Biological Corp.	FTC	Class II	1990-12-24
K904426	Panosol II Uva-218	National Biological Corp.	FTC	Class II	1990-12-24
K903643	Deknatel Microflex Ophthalmic Polypropylene Suture	Deknatel, Inc.	GAW	Class II	1990-12-24
K903224	Episensor	Palex Intl. SA	BSP	Class II	1990-12-24
K902993	Systems Flow 2000	Universal Hydrotech, Inc.	KPL	Class II	1990-12-24
K905621	Ellipse 2.3	Everest & Jennings, Inc.	IOR	Class I	1990-12-21
K905585	Patient Exam Gloves(mfg: Liaoning Machinery)	Pioneer Trading Co.	LYY	Class I	1990-12-21
K905442	Mrt35-Sp	Toshiba America Mri, Inc.	LNH	Class II	1990-12-21
K905325	X-L and X-Lx	Ivoclar North America, Inc.	EJT	Class II	1990-12-21
K905097	Micro-Aire Model Number: Mk-426	Micro Surgical Instruments Corp.	HBE	Class II	1990-12-21
K905012	Sterile Surgical Gloves/double Glover	American Advisors, Inc.	KGO	Class I	1990-12-21
K904671	Qar Handpiece	Collagen Corp.	EFB	Class I	1990-12-21
K904553	Bone Staple(s)	Synthes (USA) Products LLC	JDR	Class II	1990-12-21
K904534	Enema Bulb	R.A.C., Inc.	FCE	Class I	1990-12-21
K904527	Kapper	Senair-Mot	EJI	Class II	1990-12-21