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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3421 of 3526

510(k) clearances, page 3421 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K782080	Veneer System, Mostique Laminate	Caulk Co., Div. Dentsply	KLE	Class II	1979-01-26
K782068	Mvs Unit, Model Seu-8 and Deu-8, 80	Dentsply Intl.	EHZ	Class I	1979-01-26
K782056	Cord, Enterobacteriaceae Biochemical	Vitek Systems, Inc.	JSS	Class I	1979-01-26
K782025	Gentamicin Fluroimmunassay Kit	Technia Diagnostics, Ltd.	LCQ	Class II	1979-01-26
K781903	Ria Kit, Quantitope Cortisol	Kallestad Laboratories, Inc.	CGR	Class II	1979-01-26
K781469	Positive Placement Anethesia Kit	Arrow Intl., Inc.	CAZ	Class II	1979-01-26
K781313	Vision-Stimulator, Cam	Clement Clarke, Inc.	HPL	Class I	1979-01-26
K790083	Catheter, Arterial Line	Namic	DQY	Class II	1979-01-25
K790082	Arterial Extension Set	Namic	DQO	Class II	1979-01-25
K782158	Scanner-Sv	Hrl, Inc.	IYO	Class II	1979-01-25
K790101	Isolation Sleeve, Model 346-01	Intermedics, Inc.	DXY	Class III	1979-01-24
K790100	Isolation Sleeve, Model 348-01	Intermedics, Inc.	DXY	Class III	1979-01-24
K790099	Isolation Sleeve, Model 347-01	Intermedics, Inc.	DXY	Class III	1979-01-24
K790098	Isolation Sleeve, Model 349-01	Intermedics, Inc.	DXY	Class III	1979-01-24
K782095	Stopcocks, Manifolds	Namic	DTL	Class II	1979-01-23
K782036	Tremor Monitor	Columbus Instruments Intl. Corp.	GYD	Class II	1979-01-23
K781848	Pump, Balloon Model 10	Avco Medical Products	DSP	Class II	1979-01-23
K790009	Ice Pack, Reusable Flexible	Ackrad Laboratories	IME	Class I	1979-01-22
K782174	Pressure Alarm	Thompson Respiration Products, Inc.	CAP	Class II	1979-01-22
K782122	Hearing Aid, Model Aa	Dahlberg Electronics, Inc.	ESD	Class I	1979-01-22
K782121	Hearing Aid, Model Gb	Dahlberg Electronics, Inc.	ESD	Class I	1979-01-22
K782030	Laser System, Sharplan 791/He, CO2	Laser Industries, Ltd.	GEX	Class II	1979-01-22
K781751	Catheter, Akron Foley Teflon	Latex Ind., Inc.	KOD	Class II	1979-01-22
K781706	Respirator/gill 1/Simv	Chemetron Medical Products, Inc.	CBO	Class II	1979-01-22
K781664	Silastic Nephrostomy System	Dow Corning Corp. Healthcare Industries Materials	GBO	Class I	1979-01-22
K782114	Monitor, Oxychek Oxygen	Critikon Company, LLC	CCL	Class II	1979-01-18
K790050	Sponges, Stanford Sterile Lap	Stanford Professional Products	GDY	Class I	1979-01-17
K790039	Counter, Disposable Surgical Needle	Anago, Inc.	MMK	Class II	1979-01-17
K790025	Counter Check, H001, H002, H003	Diagnostic Technology, Inc.	KSF	Class II	1979-01-17
K790005	Administration Set, Enema	Kelsar Corp.	FCE	Class I	1979-01-17
K782157	Irma Test, Nordiclab Ferritin	Nordiclab Intl.	JMG	Class II	1979-01-17
K782155	General Equipment Cover	Domico Med-Device, LLC	IZL	Class II	1979-01-17
K782134	Filter for Hyperalimentation Set	Travenol Laboratories, S.A.	FPA	Class II	1979-01-17
K782103	Ria Kit, Neonatal T4	Serono Laboratories, Inc.	CDX	Class II	1979-01-17
K782098	Reagent, Lysing and Hemoglobin	Dade, Baxter Travenol Diagnostics, Inc.	GGK	Class I	1979-01-17
K782094	Hilar	Hi Chem, Inc.	CGX	Class II	1979-01-17
K782054	Laser, CO2 Surgical	Cavitron Corp.	HHR	Class II	1979-01-17
K782052	Processor, K750 Computer/data	Kallestad Laboratories, Inc.	JQP	Class I	1979-01-17
K782048	Test Kit, Iif-Ana	Medica Corp.	DHN	Class II	1979-01-17
K782043	Indicator, Bipolar Temperature	Micronex, Inc.	FLL	Class II	1979-01-17
K782035	Hemespec	Helena Laboratories, Corp.	JJQ	Class I	1979-01-17
K782020	Infusion Pump, Model 5000	Sigmamotor, Inc.	FRN	Class II	1979-01-17
K782019	Cutter 888-00 Infusion Pump	Sigmamotor, Inc.	FRN	Class II	1979-01-17
K782003	Band Aid* Adhesive Bandages	Johnson & Johnson Professionals, Inc.	FPX	Class I	1979-01-17
K781945	Glucose Oxidase Reagent	Fermco Biochemics, Inc.	CGA	Class II	1979-01-17
K781937	Prothesis, Metacarpal	Cutter Laboratories, Inc.			1979-01-17
K781886	Dialysate Delivery System	Cordis US Corp.	FKP	Class II	1979-01-17
K781813	Solution Administration, Tip Protector	Travenol Laboratories, S.A.	FPA	Class II	1979-01-17
K781806	Reagent System, Inorganic Phosphorus	Sigma Chemical Co.	CEO	Class I	1979-01-17
K781803	Filter, Eyrpur Disposable Leukocite	Metrix Teknika, Inc.	GKT	Class II	1979-01-17