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 2212 of 3531

510(k) clearances, page 2212 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K935302	Osher Surgical Gonio/posterior Pole Lens	Ocular Instruments, Inc.	HKS	Class I	1994-04-01
K935099	Sunglasses	Taiwan Tong AI Co., Ltd.	HQY	Class I	1994-04-01
K933175	Greenwald Control Tip Ureteroscopic Electrode	Greenwald Surgical Co., Inc.	FAS	Class II	1994-04-01
K933174	Greenwald Flexible Endoscopic Electrode	Greenwald Surgical Co., Inc.	FAS	Class II	1994-04-01
K933173	Greenwald Control-Tip Cystoscopic Electrode	Greenwald Surgical Co., Inc.	FAS	Class II	1994-04-01
K932306	Microinfusor	Diversatek Healthcare Inc	FFX	Class II	1994-04-01
K932240	Model 5200-10,5200-12 Hi-Low Elec. Parrallel Bars	Bailey Mfg. Co.	IRR	Class I	1994-04-01
K932131	Mid Labs Twin Illuminator	Medical Instrument Development Laboratories, Inc.	EQH	Class I	1994-04-01
K931175	Schuster Disposable Balloon Probe	Diversatek Healthcare Inc	FAP	Class II	1994-04-01
K921454	Fukuda Denshi Model Hg-301	Fukuda Denshi USA, Inc.	DQA	Class II	1994-04-01
K921273	Easimist Ultrasonic Nebulizer	Medix Corp.	CAF	Class II	1994-04-01
K941015	Ormco System 1+ (Tm)	Ormco Corp.	DYH	Class II	1994-03-31
K941003	Aurium 20% (Low Gold Crown and Bridge Alloy)	Argen Precious Metals, Inc.	EJT	Class II	1994-03-31
K941002	Aurium X6 (Medium Gold Crown and Bridge Alloy)	Argen Precious Metals, Inc.	EJT	Class II	1994-03-31
K940929	Aurium 50Y	Argen Precious Metals, Inc.	EJT	Class II	1994-03-31
K940901	Non-Woven Sponge	Medical Insights, Inc.	EFQ	Unclassified	1994-03-31
K940865	Aurium D17 (High Gold Crown & Bridge Alloy)	Argen Precious Metals, Inc.	EJT	Class II	1994-03-31
K940845	System 1	Sybron Dental Specialties, Inc.	DYH	Class II	1994-03-31
K940691	Wet Dressing	Medtrax Industries, Inc.	FRO	Unclassified	1994-03-31
K936308	Endex Endoscopic Positioning System	Andronic Devices, Ltd.	FQO	Class I	1994-03-31
K936255	Custom Cv Pack	Associated Medical	KDD	Class I	1994-03-31
K936141	Unipower Rechargeable Battery Pack	Unipower Corp.	BXP	Class I	1994-03-31
K936097	Video Cameras, Encoscopic and Surgical	Micromedical Devices, Inc.	GCJ	Class II	1994-03-31
K936084	Omni Warm Gel Packs	Omni Therm, Inc.	IMD	Class I	1994-03-31
K935815	Erbotom Icc 50	Erbe USA Inc	GEI	Class II	1994-03-31
K935170	Cardiovascular and Vascular Guidewire Modifications	Lake Region Mfg., Inc.	DQX	Class II	1994-03-31
K934581	Scimed 5, 7, and 8 French Angiographic Catheters	Scimed Life Systems, Inc.	DQO	Class II	1994-03-31
K933941	Menlo Care Urinary Diversion Stent	Menlo Care, Inc.	FAD	Class II	1994-03-31
K933927	Hep-2 Culture Cell	Neogenex	KIR	Class I	1994-03-31
K933836	Hbm Hemoglobinometer	Artel, Inc.	GIG	Class II	1994-03-31
K933671	Ultracam	Dental Vision Direct, Inc.	EIA	Class I	1994-03-31
K933324	Skin Biopsy Device	Nhr, Inc.	MJG	Class I	1994-03-31
K932895	River Pump	River Medical, Inc.	FRN	Class II	1994-03-31
K932533	Smartscope	Insight Medical Corp.	JXE	Class II	1994-03-31
K932077	Model 151 Fetal Monitor	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1994-03-31
K931458	Medipak Ambulatory Infusion Pump	Medication Delivery Devices, Inc.	FRN	Class II	1994-03-31
K931261	Spectropad System	Smi	ILY	Class II	1994-03-31
K931076	Arthoscope and Accessories	Meditron Devices, Inc.	HRX	Class II	1994-03-31
K930852	Olympus Suction Pump Model Kv-4	KEYMED (Medical & Industrial Equipment) Ltd	JCX	Class II	1994-03-31
K930813	Pistol Suction/irrigation Probe	Origin Medsystems, Inc.	GCJ	Class II	1994-03-31
K930742	Pegasus Proactive Wheelchair Cushion	Pegasus Airwave, Inc.	ITI	Class II	1994-03-31
K926165	Ceramco Crowns and Bridges	Asap Dental Lab, Ltd.	EJH	Class II	1994-03-31
K924603	Pharmetrix Minipump Model 5120	Pharmetrix, Inc.	FRN	Class II	1994-03-31
K941023	Rarex Green Fast	Mci Optonix	EAM	Class I	1994-03-30
K940909	Electrosurgical Monopolar Handswitching Pencil W/removable Blade	Debusk Technology Corp.	GEI	Class II	1994-03-30
K940694	Xeroform Petrolatum Dressing	Medtrax Industries, Inc.	FRO	Unclassified	1994-03-30
K940693	Petrolatum Dressing	Medtrax Industries, Inc.	FRO	Unclassified	1994-03-30
K940203	Triple Lumen Urodynamic Catheter with Radiopaque Markers	Life-Tech Intl., Inc.	FEN	Class II	1994-03-30
K940199	Dissector	Automated Medical Products Corp.	GCJ	Class II	1994-03-30
K940187	Envoy Guiding Catheter	Cordis Neurovascular, Inc.	DQY	Class II	1994-03-30