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 2694 of 3530

510(k) clearances, page 2694 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883806	Rocket Intrauterine Sound	A & A Medical, Inc.	HHM	Class I	1988-10-31
K883765	Tbg 125I Ria Kit, Radioimmuno. of Serum Thyroxine	Biotecx Laboratories, Inc.	KHQ	Class II	1988-10-31
K883699	B3000/b3000m Magnetic Resonance Imaging Scanner	Fonar Corp.	LNH	Class II	1988-10-31
K883646	Behring Turbitimer	Behring Diagnostics, Inc.	JJQ	Class I	1988-10-31
K883640	Kd One-Stage Prothrombin Time Test	King Diagnostics, Inc.	JPA	Class II	1988-10-31
K883637	Kd 0.02 M Calcium Chloride Solution	King Diagnostics, Inc.	JPA	Class II	1988-10-31
K883635	Kd 0.1 M Sodium Citrate Solution	King Diagnostics, Inc.	JPA	Class II	1988-10-31
K883539	Sr1 System Automated Photometric Analyzer	Serono-Baker Diagnostics, Inc.	JJE	Class I	1988-10-31
K883432	Immunoccult-Lxi	Intl. Immunoassay Laboratories, Inc.	KHE	Class II	1988-10-31
K883408	Naturalyte Mixer	National Medical Care, Medical Products Div., Inc.	FIN	Class II	1988-10-31
K883337	Pl 20/20 Infant Vision Tester	Optimed Technologies, Inc.	HOX	Class I	1988-10-31
K883267	Irma-Count (Tm) Shbg (Sex Hormorne Bind Globulin)	Siemens Healthcare Diagnostics Inc.	CDZ	Class I	1988-10-31
K883256	Bio Therapy (Tm) Advanced Pressure Relief System	Bio Clinic Co.	FNM	Class II	1988-10-31
K883182	Fiagen Rubella Igg	Cyberfluor, Inc.	LFX	Class II	1988-10-31
K883078	Insulin Syringe	Select Sources, Inc.	FMF	Class II	1988-10-31
K883033	Piston Syringe with Needle	Select Sources, Inc.	FMF	Class II	1988-10-31
K882896	One-Step Hcg	Wampole Laboratories	DHA	Class II	1988-10-31
K882629	Directigen Respiratory Syncytial Virus Test Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	GQG	Class I	1988-10-31
K882048	Meditron Endolav Model El-100	Xylog Corp.	KNS	Class II	1988-10-31
K881422	Coe Pak Auto Mix, Regular or Hard Set	Coe Laboratories, Inc.	EMA	Class II	1988-10-31
K880690	Siemens Pacs/i-a	Siemens Gammasonics, Inc.	IZI	Class II	1988-10-31
K884167	Tech Med Nitrous Oxide Sedation Nasal Inhaler Cir.	Technical Medical Products, Inc.	CBN	Class II	1988-10-28
K883956	Bio-Medicus Tubing Connectors	Bio Medicus, Inc.	DTL	Class II	1988-10-28
K883916	Rotating Hemostatic Valve	Devices for Vascular Intervention, Inc.	DQY	Class II	1988-10-28
K883908	3D Vascular Recorder	D. E. Hokanson, Inc.	JOM	Class II	1988-10-28
K883877	Bm-103 Battery Module	Datex Division Instrumentarium Corp.	DQA	Class II	1988-10-28
K883526	Porges Stepped Neoplex Dilator	Porges Corp.	KNQ	Class II	1988-10-28
K883314	Pmt 3721-1 Epidural Kit	Progress Mankind Technology	CAZ	Class II	1988-10-28
K883058	Solcotrans Ortho. Drainage/reinfusion System	Solco Basle, Inc.	CAC	Class II	1988-10-28
K882804	0.014 Peripheral Guide Wire	Intensive Technology, Inc.	DQX	Class II	1988-10-28
K882682	Compat Enteral Delivery System	Sandoz Nutrition	KNT	Class II	1988-10-28
K882462	Permanent Pacing Lead Model Rxbj Series	Oscor Medical Corp.	DTB	Class III	1988-10-28
K882345	Permanent Pacing Leads Pybj Series	Oscor Medical Corp.	DTB	Class III	1988-10-28
K884313	Model Sl45 Surgilase CO2 Surgical Laser Systems	Surgilase, Inc.	GEX	Class II	1988-10-27
K884311	Model Sl60 Surgilase CO2 Surgical Laser Systems	Surgilase, Inc.	GEX	Class II	1988-10-27
K884185	Ciba Corning Magic Lite Total Ige Immunoassay	Ciba Corning Diagnostics Corp.	DHB	Class II	1988-10-27
K884147	Immunochemical Determination of Immunoglobulin M	Orion Diagnostica, Inc.	DFT	Class II	1988-10-27
K884074	Immunochemical Determination of Immunoglobulin G	Orion Diagnostica, Inc.	DAH	Class II	1988-10-27
K883949	Antinuclear Antibody (Ana) Test (Mouse Liver Sect)	Immco Diagnostics, Inc.	LKJ	Class II	1988-10-27
K883907	Sceptorpette System	BD Becton Dickinson Vacutainer Systems Preanalytic	LRG	Class II	1988-10-27
K883902	Infusa-Plate	Kalajian Ent.	FRN	Class II	1988-10-27
K883883	Antinuclear Antibody (Ana) Test (Hep-2 Cells)	Immco Diagnostics, Inc.	LKJ	Class II	1988-10-27
K883881	Modified Model 2001 Fiber Optics Catheter	Metatech Corp.	GWM	Class II	1988-10-27
K883746	Micromedic Ferritin Irma Kit	Icn Micromedic Systems	DBF	Class II	1988-10-27
K883371	Multi-Allergen Ige Fastscreen V (T1,t3,t5,t7,t10)	3M Company	DHB	Class II	1988-10-27
K883187	Scalp Hydrobath/treatment Delivery System	Intl. Health Technology, Inc.	ILJ	Class II	1988-10-27
K884165	Muscle Examination & Exercise Dosimeter (Meed) Sys	Spark Instruments & Academics, Inc.	LBB	Class II	1988-10-26
K884052	Gillum's Wheelchair Width Reducing Attachment	Professional Service Unltd.	KNN	Class I	1988-10-26
K883467	The Saxon Spermicidal Condom	Circle Rubber Corp.	HIS	Class II	1988-10-26
K883192	Smi 3000 Airbed	Smi Patientcare, Inc.	IOQ	Class II	1988-10-26