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 2291 of 3531

510(k) clearances, page 2291 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K921271	Electrosurgical Unit	E & M Engineering, Inc.	GEI	Class II	1993-07-02
K921020	Hargis Self Retraction System	Medin Corp.	GAD	Class I	1993-07-02
K921019	Hargis Rectal Self Retration System	Medin Corp.	GAD	Class I	1993-07-02
K921017	Hargis Sr2 Self-Retraction System	Medin Corp.	GAD	Class I	1993-07-02
K915258	Service Deionization Syst/di Tank Exchange Program	Aqua-Med Systems, Inc.	FIP	Class II	1993-07-02
K931584	Scimed Transport Steerable Guide Wire and Access.	Scimed	DQX	Class II	1993-07-01
K931394	Cm5000r Remote Indicator	Canadian Monaghan, Ltd.	CAP	Class II	1993-07-01
K931340	Grasp Forceps/scissors/needle Holder/dissector	Baxter Healthcare Corporation	GCS	Class II	1993-07-01
K931287	Cm7000 Remote Indicator	Canadian Monaghan, Ltd.	CAP	Class II	1993-07-01
K931156	Cone Cath	Sierra Laboratories, Inc.	EXJ	Class I	1993-07-01
K930816	Hepa Filtered Hme	Intertech Resources, Inc.	CAH	Class II	1993-07-01
K930154	El2-Series Blood Collection Reervoir	Electromedics, Inc.	DTN	Class II	1993-07-01
K923595	System 7110 Non-Invasive Blood Pressure Monitor	Advanced Medical Instruments, Inc.	DXN	Class II	1993-07-01
K921048	Bp8800t/8000ir/8300g Non-Invasive Blood Pres. Syst	Colin Medical Instruments Corp.	DXN	Class II	1993-07-01
K915697	Critikon Vital Signs Module	Critikon Company, LLC	DXN	Class II	1993-07-01
K915634	Fresenius Pd+ Exchange Device	Fresenius USA, Inc.	EKX	Class I	1993-07-01
K914210	Vas-Cath Dualator(tm) Vessel Dilator	Vas-Cath, Inc.	FKA	Class II	1993-07-01
K914162	Vas-Cath Flexxicon 2 Dual Lumen Dialysis Catheters	Vas-Cath, Inc.	LFJ	Class II	1993-07-01
K932458	Document Enzyme	Casco Standards	JJY	Class I	1993-06-29
K932409	Sas(tm) Serum/urine Hcg	SA Scientific, Ltd	DHA	Class II	1993-06-29
K932113	Cannabinoid Urine Controls	Diagnostic Reagents, Inc.	JJX	Class I	1993-06-29
K932076	Liquichek Spinal Fluid Control Levels I and II	Bio-Rad	JJY	Class I	1993-06-29
K932042	Quickvue One-Step Hcg Combo	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	1993-06-29
K931832	The Hill Adjustable Ha90	Hill Laboratories	INQ	Class I	1993-06-29
K931551	Kodak Ektascan Imagelink System (Keis)	Eastman Kodak Company	LMD	Class I	1993-06-29
K930679	Direct Bilirubin	Horizon Diagnostics, Inc.	CIG	Class II	1993-06-29
K930264	Matrix Elecdt & Vacupulls	Matrix Electromedical, Inc.	LIH	Class II	1993-06-29
K925632	Balt Guiding Catheter	Target Therapeutics	DQO	Class II	1993-06-29
K925447	Oti Orthopedic Wire System	Osteo Technology, Inc.	JDQ	Class II	1993-06-29
K925054	Infrared Lamp	Lumiscope Co., Inc.	ILY	Class II	1993-06-29
K925036	Handy Vibro Belt	Cosmesearch, Inc.	ISA	Class I	1993-06-29
K924922	Cvis Insight Imaging Catheter	Cardiovascular Imaging Systems, Inc.	DQO	Class II	1993-06-29
K924227	Cri Cynosar Catheter	Catheter Research C/O Burditt, Bowles & Radzius	DRA	Class II	1993-06-29
K923902	Sterile Dental Kits	Professional Sterile Systems, Inc.	EKJ	Class I	1993-06-29
K922344	Omron Tympanic Thermometer Mc-500	Omron Healthcare Co., Ltd.	FLL	Class II	1993-06-29
K922036	Sonopuls 591	Henley Intl.	IMG	Class II	1993-06-29
K921985	Arthroscope & Accessories	Optimed Technologies, Inc.	HRX	Class II	1993-06-29
K921908	Novolinpen Dial-a-Dose Insulin Delivery Device	Novo Nordisk Pharmaceuticals, Inc.	FMF	Class II	1993-06-29
K921247	Zephyr Infusion Catheter	Target Therapeutics	KRA	Class II	1993-06-29
K915633	Mod. Type 9230 Temp 1 and Temp 2 System Athena	S & W Medico Teknik	FLL	Class II	1993-06-29
K915528	Bhr Bipolar Femoral Head Component	Implantology Corp.	LZY	Class II	1993-06-29
K931620	Opti-Free Contact Lens Case	Alcon Laboratories	LRX	Class II	1993-06-28
K925736	Non-Pres Sunglasses/spec Frames (Plastic & Metal)	Eyeworks 3	HQY	Class I	1993-06-28
K925200	Berichrom Heparin	Behring Diagnostics, Inc.	KFF	Class II	1993-06-28
K924516	Op3/vp4	Huntleigh Technology, Inc.	HGL	Class II	1993-06-28
K923663	Multitrol Immunology Control	Behring Diagnostics, Inc.	JJY	Class I	1993-06-28
K923361	i.v. Start Kit, Sterile, Disposable	Trinity Laboratories, Inc.	LRS	Class II	1993-06-28
K915742	Turbiquant Asl	Behring Diagnostics, Inc.	GTQ	Class I	1993-06-28
K931650	Microvasive Insurg Geenen Cbd Guide Wire	Boston Scientific Corporation	OCY	Class II	1993-06-25
K931523	Quantimetrix C-Clear(tm)	Quantimetrix Corp.	JMA	Class I	1993-06-25