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 2611 of 3530

510(k) clearances, page 2611 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K894592	Lamano Directors	Marlo Surgical Technology	GCM	Class II	1989-09-08
K894419	Gastro Enterological Bioptome	Boston Scientific Corporation	KNW	Class II	1989-09-08
K894049	Immunocoat Progesterone Radioimmunoassay Kit	Pantex, Div. Bio-Analysis, Inc.	JLS	Class I	1989-09-08
K893992	Noetix, Biopsy Needle	Noetix, Inc.	KNW	Class II	1989-09-08
K893965	Prolong Intravascular Catheter	Baxter Healthcare Corporation	FOZ	Class II	1989-09-08
K893836	Eplab (Electrocardiographic Monitor)	Quinton Electrophysiology Corp.	DSH	Class II	1989-09-08
K893723	Lori-Model L, Canal in-the-Ear Instrument	Lori Medical Laboratories, Inc.	ESD	Class I	1989-09-08
K893722	Lori-Model H, Half Concha in-the-Ear Instrument	Lori Medical Laboratories, Inc.	ESD	Class I	1989-09-08
K893721	Lori-Model O, Low Profile in-the Ear Instrument	Lori Medical Laboratories, Inc.	ESD	Class I	1989-09-08
K893553	Bipolar Electrosurgical Snare	Everest Medical Corp.	FDI	Class II	1989-09-08
K893263	Latex Examination Gloves	Regent Group Co., Ltd.	LYY	Class I	1989-09-08
K893050	Patient Examination Gloves	Paratex Product Co., Ltd.	LYY	Class I	1989-09-08
K892191	Patient Examination Gloves (Vinyl)	Hsing YI Plastics Processing Co, Ltd.	LYZ	Class I	1989-09-08
K892108	Sterile Natural Latex Surgical Gloves	Ruhn Chang Industrial Co., Ltd.	KGO	Class I	1989-09-08
K885168	Rubenstein Ureteral Stone Fragment Brush	Boston Scientific Corporation	FGO	Class II	1989-09-08
K884712	Esophageal and Pyloric Balloon Dialators	Primrose Medical, Inc.	KNQ	Class II	1989-09-08
K884709	Endoscopes & Access.(sclerotherapy/transbronchial)	Primrose Medical, Inc.	ODD	Class II	1989-09-08
K875317	Electrical Muscle Stimulator Model Myoaid	Electro Therapeutic Devices Inc	IPF	Class II	1989-09-08
K894838	Hemodialysis Single Patient System (Sps) 550 Vsb	Baxter Healthcare Corporation	FKP	Class II	1989-09-07
K894783	Peritoneal Dial. Tita. Cath Adapter & Locking Cap	Baxter Healthcare Corporation	KDJ	Class II	1989-09-07
K894683	Fabfoam #302	Jewell Industries	JAD	Class II	1989-09-07
K894542	Elscint's Exel 2400E CT Scanner	Elscint, Inc.	JAK	Class II	1989-09-07
K894483	Glucose-Hk Test (Glu-Hk) Item #65415	Em Diagnostic Systems, Inc.	CFR	Class II	1989-09-07
K894482	Lactate Dehydrogenase Test (Ld) Item #65418	Em Diagnostic Systems, Inc.	CFJ	Class II	1989-09-07
K894290	Access Tm	Diasonics, Inc.	LNH	Class II	1989-09-07
K894265	Dsl 17A-Oh Progersterone (Dsl #6800)	Diagnostic Systems Laboratories, Inc.	JLX	Class I	1989-09-07
K894218	Nova Nucleus Clinical Chemistry System	Nova Biomedical Corporation	JGS	Class II	1989-09-07
K894170	Devon Disposable Head Positioner Cover	Devon Industries, Inc.	KME	Class I	1989-09-07
K894063	Triglyceride (Gpo) Trinder Reagent	Sigma Diagnostics, Inc.	JGY	Class I	1989-09-07
K894060	Esse Quattro/esse Uno	Eurodent, Inc.	KLC	Class I	1989-09-07
K894059	Isolight	Eurodent, Inc.	EAZ	Class I	1989-09-07
K893811	Sakura Prep Ai Automatic Liquid Handling System	Sakura Finetek USA Inc	JQW	Class I	1989-09-07
K893390	Modified Pristine Culture Catheter	Hml Medical, Inc.	KOD	Class II	1989-09-07
K892622	Patient Examination Gloves (Latex)	Latexon Co., Ltd.	LYY	Class I	1989-09-07
K890087	Acudata Indicatens Model 5M	Acudata Software	GZJ	Class II	1989-09-07
K884970	Pinset	Safety Diagnostics, Inc.	JKA	Class II	1989-09-07
K894848	Haemophilus Test Medium (Broth)	Regional Media Laboratories	JSO	Class II	1989-09-06
K894431	Modified Labeling to Permanent Lead Introducer	Daig Corp.	DYB	Class II	1989-09-06
K894127	Lumiscope Model 1000/Apcc Model 1000	Lumiscope Co., Inc.	GZJ	Class II	1989-09-06
K893899	Sterile Latex Surgical Gloves	Life Force Laboratories, Inc.	KGO	Class I	1989-09-06
K892176	Correct Touch Surgeons Gloves	Ampri Rubberware Industries Sdn Bhd	KGO	Class I	1989-09-06
K891676	Arvee Apnea Monitor, Model 2400	Arvee Medical, Inc.	BZQ	Class II	1989-09-06
K891622	Sterile Surgical Natural Latex Gloves	CT Intl.	KGO	Class I	1989-09-06
K891118	Sterling TENS	Armstrong Industries, Inc.	GZJ	Class II	1989-09-06
K890913	Sdu 800 Diagnostic Ultrasound Instrument	Shimadzu Precision Instruments, Inc.	IYO	Class II	1989-09-06
K894987	Model #520/525 Ed/recovery Stretcher	Medmark, Inc.	INW	Class I	1989-09-05
K894984	Mascot Lab Sponge	Mascot, Inc.	GDY	Class I	1989-09-05
K894960	E.z. Lock Wheelchair Restraint Device	E.Z. Lock, Inc.	KNN	Class I	1989-09-05
K894926	Stat-Pad	Hettel Accessories, Inc.	IMD	Class I	1989-09-05
K894849	Sentry Latex Examination Gloves	Vijayshree Spinning Mills, Ltd.	LYY	Class I	1989-09-05