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 2026-11-05, 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 2363 of 3531

510(k) clearances, page 2363 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920645	Orthodontic Elastics Bands	Masel Industries, Inc.	EJF	Class I	1992-07-28
K920449	Pointe 750 Glycometer	Horiba Instruments Incorporated	LCP	Class II	1992-07-28
K920026	Nobles-Lai Imaging System	Nobles-Lai Engineering, Inc.	FET	Class II	1992-07-28
K915201	Cytoguide Stereotactic Biopsy System Model Mf-Cyto	Bennett X-Ray Corp.	IZH	Class II	1992-07-28
K915170	Pymah Cold Sterilog Glutaraldehyde Monitor	Pymah Corp.	MED	Class II	1992-07-28
K913244	Ktp/532 & Ktp/yag Surgical Lasers	Charles L. Rose and Co., Inc.	GEX	Class II	1992-07-28
K910571	Biliblanket Light Meter	GE Healthcare	LBI	Class II	1992-07-28
K923177	Optical Frames	A Toz Importing Co.	HQZ	Class I	1992-07-27
K922996	Modified Site Diaphragm Cassette for Ophthalmics	Chiron Vision Corp.	KYG	Class I	1992-07-27
K922704	Coulter Maxm W/ Autoloader	Coulter Electronics, Inc.	GKZ	Class II	1992-07-27
K922538	Ventrex Allergen Disc	Hycor Biomedical	DHB	Class II	1992-07-27
K922493	American Medical Mfg. Lumbar Cpm	American Medical Corp.	BXB	Class I	1992-07-27
K922165	Atc725, Atc525, and Ap300	Gendex Corp.	IZO	Class I	1992-07-27
K922098	Cag-02A	Toshiba America Medical Systems, In.C	KXJ	Class II	1992-07-27
K921937	Nova Nucleus Clinical Chemical Syst, Modification	Nova Biomedical Corporation	JGS	Class II	1992-07-27
K921390	Xenon Light Source and Accessories	Coopervision Surgical	GCT	Class II	1992-07-27
K921326	Dade Recomboplastin S	Baxter Diagnostics, Inc.	GJS	Class II	1992-07-27
K921011	Pharmacia Cmv Igm Elisa	Pharmacia Diagnostics, Inc.	LFZ	Class II	1992-07-27
K920836	Sunglasses	A Toz Importing Co.	HQY	Class I	1992-07-27
K920738	Ace 100 Degrees Tubular Plate	Ace Orthopedic Manufacturing Co.	HRS	Class II	1992-07-27
K920614	Hemo-Band	Innovations in Access, Inc.	KOC	Class II	1992-07-27
K920604	Bivona Tracheal T-Tube Stent	Bivona Medical Technologies	BTO	Class II	1992-07-27
K920222	Healthtest Assay for Antibody to Cytomegalovirus	Akers Research Corp.	LJO	Class II	1992-07-27
K915268	Catheter Two Stage Venous Return	Dlp, Inc.	DWF	Class II	1992-07-27
K915059	Peak Flow Monitor	Spirometrics, Inc.	BZH	Class II	1992-07-27
K922535	The Terminator	Top End Wheelchair Sports, Inc.	IOR	Class I	1992-07-24
K922302	Jagwire(tm) Recanalization Guidewire	Boston Scientific Corporation	DQX	Class II	1992-07-24
K921913	Hypo-Gard	Epi Medical Products, Inc.	MMK	Class II	1992-07-24
K920135	Medroyal Angiographic Control Syringe	Medroyal, Inc.	DXT	Class II	1992-07-24
K914918	Laserscope's Microspot Dermastat	Laserscope	GEX	Class II	1992-07-24
K914772	Medix Nebulizing System Code No. 2000 and 2001	Medix Corp.	CAF	Class II	1992-07-24
K911221	Atraumatic Special Sprotte Needle	Pajunk GmbH Medizintechnologie	BSP	Class II	1992-07-24
K923350	Closed Chain Attachment, Model #820-520	Biodan Medical Systems, Ltd.	IKK	Class II	1992-07-23
K922721	Vlc Dycal II	Dentsply Intl.	EJK	Class II	1992-07-23
K922410	Scimed Avenue Coronary Guidewire Insertion Tool	Scimed Life Systems, Inc.	DQX	Class II	1992-07-23
K922196	Osteo Tibia Nail	Osteo AG	HSB	Class II	1992-07-23
K922195	Osteo Femoral Nail	Osteo AG	HSB	Class II	1992-07-23
K922194	Osteo Steinmann Pin	Osteo AG	HTY	Class II	1992-07-23
K922193	Osteo Kirschner Wire	Osteo AG	HTY	Class II	1992-07-23
K922024	Rep Spe Plus (Acid Blue) System,# 3173/3174/3175	Helena Laboratories, Corp.	CEF	Class I	1992-07-23
K921997	Cuff-M	Lorin Medical, Inc.	DXQ	Class II	1992-07-23
K921810	Curasol(tm) Wound Dressing	Healthsouth Medical Center	MGQ	Unclassified	1992-07-23
K921435	Accuprobe Mycobacterium Avium Complex Culture	Hologic, Inc.	LQF	Class I	1992-07-23
K921202	Turbinate Nasal Splint	Smith & Nephew Richards, Inc.	LYA	Class I	1992-07-23
K921195	Nasal Septal Splint	Smith & Nephew Richards, Inc.	LYA	Class I	1992-07-23
K920796	Deroyal Transparent Film Dressign	DeRoyal Industries, Inc.	MGP	Unclassified	1992-07-23
K920653	Il Test Bilirubin Total/direct	Instrumentation Laboratory Co.	CIG	Class II	1992-07-23
K920649	Compasep	Wilde-USA, Inc.	FMC	Class I	1992-07-23
K920575	Merkur 4000	F.M. Wiest USA, Inc.	FAP	Class II	1992-07-23
K920217	Max-E-Vac	Leisegang Medical, Inc.	GEI	Class II	1992-07-23