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 2026-10-29, 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 2595 of 3530

510(k) clearances, page 2595 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K892769	Patient Examination Gloves	Glw Intl. Corp.	LYY	Class I	1989-10-31
K892329	Osmometer Standard Solutions	D.R.G. Scientific Industries	JIT	Class II	1989-10-31
K892163	Patient Examination Gloves (Latex)	Canada Packers, Inc.	LYY	Class I	1989-10-31
K892138	Patient Examination Gloves (Latex)	Shanghai Latex Factory	LYY	Class I	1989-10-31
K891794	Disposable Latex Examination Gloves	Cn Asia Sdn Bhd	LYY	Class I	1989-10-31
K891670	Hedy Patient Examination Gloves (Vinyl)	Hedd Industry Corp.	LYZ	Class I	1989-10-31
K883914	Fatigmeter	K. Jimbo Co., Inc.	GWE	Class II	1989-10-31
K895967	Fastec 901 Agglutination Pattern Reader	Schiff & Co.	JJQ	Class I	1989-10-30
K895954	Laryngostat Laryngoscope Handle	Michigan Instruments	CCW	Class I	1989-10-30
K895847	Creatinine 340 (Enzymatic)	Sclavo, Inc.	CGX	Class II	1989-10-30
K895828	Innofluor Digoxin Reagent Set	Innotron of Oregon, Inc.	LCS	Class II	1989-10-30
K895826	Innofluor Digoxin Calibrator Set	Innotron of Oregon, Inc.	DLJ	Class II	1989-10-30
K895572	N-Acetylprocainamide (Napa) Calibrator Kit	Tudor Laboratories, Inc.	DLJ	Class II	1989-10-30
K895485	Bird (Ipv) Noncontinuous Ventilators	Percussionaire Corp.	NHJ	Class II	1989-10-30
K895334	Tts2600	Henley Intl.	GZJ	Class II	1989-10-30
K895287	Vma Eia Kit Yamasa	Yamasa Shoy Co., Ltd.	CDF	Class I	1989-10-30
K895211	Tts2700 Transcutaneous Electrical Nerve Stimulator	Henley Intl.	GZJ	Class II	1989-10-30
K895166	Tts2500	Henley Intl.	GZJ	Class II	1989-10-30
K895161	Tts2800	Henley Intl.	GZJ	Class II	1989-10-30
K895151	Vista Mr 2055 Hp System	Philips North America LLC	LNH	Class II	1989-10-30
K895122	Ciba Corning Magic Lite Chlamydia Immunoassay	Ciba Corning Diagnostics Corp.	LJC	Class I	1989-10-30
K895098	Biopsy Forceps	Annex Medical, Inc.	DWZ	Class II	1989-10-30
K895031	Modified Infant Nasal Cannulae Assembly	Ackrad Laboratories	BZD	Class II	1989-10-30
K895014	Baxter Baffled Tee Adapter	Baxter Healthcare Corporation	BZA	Class I	1989-10-30
K894997	Presto Diagnostic Spirometer	Tamarac Systems Corp.	BZG	Class II	1989-10-30
K894973	Respitrace Plus	Hogan & Hartson	FLS	Class II	1989-10-30
K894969	Aerovent	Monaghan Medical Corp.	BZA	Class I	1989-10-30
K894924	990 Gold	Comprehensive Holistic Dentistry	EJT	Class II	1989-10-30
K894897	Answer Dental Implement, Forceps	Tern Chien Ent. Co., Ltd.	EKJ	Class I	1989-10-30
K894896	Answer Dental Implement, Explorer	Tern Chien Ent. Co., Ltd.	EKJ	Class I	1989-10-30
K894895	Answer Dental Implements, Mirror	Tern Chien Ent. Co., Ltd.	EKJ	Class I	1989-10-30
K894836	Dart Urea Nitrogen	Coulter Electronics, Inc.	CDQ	Class II	1989-10-30
K894576	Ciba Corning Certain Lyte	Ciba Corning Diagnostics Corp.	JJR	Class I	1989-10-30
K894410	Immunodot Lyme Test	General Biometrics, Inc.	LSR	Class II	1989-10-30
K893609	Teves Ecm (Endotracheal Cardiac Monitor)	Leonides Y. Teves, M.D., P.A.	BTR	Class II	1989-10-30
K892323	Seismocardiograph - Scg(tm) 1000 Series	Seismed Instruments, Inc.	DSB	Class II	1989-10-30
K884643	1100 Vital Signs Monitor	Criticare Systems, Inc.	DSI	Class II	1989-10-30
K884126	E-Ram	Reynolds Medical, Ltd.	DSH	Class II	1989-10-30
K896033	Fdp Collection Tubes	Medical Diagnostic Technologies, Inc.	JCO	Class II	1989-10-27
K895995	Rheumelisa Assay for Ss-B/la Autoantibodies	Lipogen, Inc.	LJM	Class II	1989-10-27
K895866	Dird Ingant O2 (Bio 2 Hood)	Bird Products Corp.	BYL	Class I	1989-10-27
K895786	Endoguide Product Line: Ex0120, Ex0300 and Ex0400	Luxar Corp.	GEX	Class II	1989-10-27
K895747	Ventilarm II Portable Airway Pressure Monitor	Hudson Oxygen Therapy Sales Co.	CAP	Class II	1989-10-27
K895666	Bun (Kinetic)	Boehringer Mannheim Corp.	CDQ	Class II	1989-10-27
K895388	Shiley Elbow 15Mm Swivel Connector	Shiley, Inc.	BZA	Class I	1989-10-27
K895351	Respironics Infant Bageasy	Respironics, Inc.	BTM	Class II	1989-10-27
K895231	Catalog No. 1755 1S0-Neb, a Filtered Nebulizer	Hudson Oxygen Therapy Sales Co.	CAF	Class II	1989-10-27
K895209	Filmfax	Discovery Systems, Inc.	LMD	Class I	1989-10-27
K895185	First Medic Model 610P	First Medical Devices Corp.	LDD	Class II	1989-10-27
K895163	Force II	American Orthodontics	DYH	Class II	1989-10-27