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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3329 of 3528

510(k) clearances, page 3329 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802179	Cardioscope J200	Telectronics, Inc.	DRS	Class II	1980-11-12
K802166	Model as* 7B Autosyringe Infusion Pump	Baxter Healthcare Corporation	FLN	Class II	1980-11-12
K802153	Cbc Pap Test Kit	Calbiochem-Behring Corp.	JFH	Class II	1980-11-12
K802149	Tm-5 Intracranial Pressure Monitor	Nicolet Biomedical Instruments	GWM	Class II	1980-11-12
K802029	Objective Refractor	Zeiss Humphrey System	HKO	Class I	1980-11-12
K801986	Datason Db System	General Electric Co.	IYO	Class II	1980-11-12
K801974	Analytic Tech. Metal Point Heater #3001	Analytic Technology	ELA	Class I	1980-11-12
K801922	Tuttifrutti (Non-Pres. Sunglasses)	Safety Plastics of New York	HQY	Class I	1980-11-12
K801908	Si-14	Kmi Medical, Inc.	KDC	Class I	1980-11-12
K802322	Model Sd-1 Disintegrator	Northgate Research, Inc.	FFK	Class II	1980-11-10
K802805	Nemectrodyn 5	Nemectron Medical, Inc.			1980-11-05
K802629	Steri-Sleeve	Cordis US Corp.	DQO	Class II	1980-10-31
K802621	Emit-Stm Ethyl Alcohol Assay	Syva Co.	DMT	Class II	1980-10-31
K802620	Emit-Stm Ethyl Alcohol Urine Calibrator	Syva Co.	DNN	Class II	1980-10-31
K802619	Drug Detection System	Syva Co.	JJQ	Class I	1980-10-31
K802618	Emit-Stm Ethyl Alcohol Urine Controls	Syva Co.	DKC	Class I	1980-10-31
K802617	Emit-Stm Barbiturate Assay	Syva Co.	DIS	Class II	1980-10-31
K802616	Emit-Stm Benzodiazepine Assay	Syva Co.	JXM	Class II	1980-10-31
K802615	Emit-Stm Opiate Assay	Syva Co.	DJE	Class II	1980-10-31
K802606	Leg Bag Extension Tube	Associated Medical Products Co.	KNX	Class II	1980-10-31
K802599	Arthroscopic Fat Pad Retractor	The Anspach Effort, Inc.	GAD	Class I	1980-10-31
K802585	Feeding Tubes in Silicone 5,6,8&10 Sizes	The Healthcare Group Laboratories, Inc.	KNT	Class II	1980-10-31
K802566	Beta Lactamase Reagent Disk	Carr-Scarborough Microbiologicals, Inc.	JTO	Class I	1980-10-31
K802565	3Mp-7 Scanner Respiratory Monitor	Bird Products Corp.	CAP	Class II	1980-10-31
K802563	Transette System/collection & Transp	Inolex Corp./Div of Biomedical	JTW	Class I	1980-10-31
K802561	Hi Volume Pumping Chamber	Acacia, Inc.	JTB	Class I	1980-10-31
K802558	Surcan Knee Holding Device	Bend Orthopedic & Fracture Clinic	FWZ	Class I	1980-10-31
K802555	Cottrell 90/90 Backtrac	Lossing Orthopedic, Inc.	HST	Class I	1980-10-31
K802538	Basin Pack	Texas Medical Products, Inc.	FNY	Class I	1980-10-31
K802516	Foley Catheter	Abco Dealers, Inc.	KOD	Class II	1980-10-31
K802503	Micro-Sugical Power Instrument System	Spire Medical, Inc.	EQJ	Class I	1980-10-31
K802482	Keofeed (R) Easy-Fill Enteric Feed Bag	Health Development Corp.	KNT	Class II	1980-10-31
K802481	7French Flow Directed Triple Lumen Cath	Waters Assoc., Inc.	DYG	Class II	1980-10-31
K802479	Surgical Knives & Probes	Eder Instrument Co, Inc.	HXB	Class I	1980-10-31
K802477	Misty Nebulizer	Airlife, Inc.	CAF	Class II	1980-10-31
K802468	T3 Uptake Test System	American Diagnostic Corp.	KHQ	Class II	1980-10-31
K802467	Tsh Radioimmunoassay Kit	American Diagnostic Corp.	JLW	Class II	1980-10-31
K802464	Oreai-Q-Tu Test	Organon LLC	KHQ	Class II	1980-10-31
K802463	Micro-Surgical Power Instrument System	Spire Medical, Inc.	ERL	Class II	1980-10-31
K802461	Endab Digitoxin Enzyme Immunoassay Kit	IMMUNOTECH s.r.o.	LCW	Class II	1980-10-31
K802456	T4-Squibb Ria Kit	E. R. Squibb & Sons, Inc.	CDX	Class II	1980-10-31
K802455	Estriol-Squibb Ria Kit	E. R. Squibb & Sons, Inc.	CGI	Class I	1980-10-31
K802450	Gestate Slide Eiken Kit Agg. Method Hum	Syn-Kit, Inc.	JHJ	Class II	1980-10-31
K802446	Ranawat Esf Total Condylar Knee	Howmedica Corp.	HRY	Class II	1980-10-31
K802442	Low Back Posture Pillow	Body Therapeutics, Inc.	IQK	Class I	1980-10-31
K802436	Centrifichem Albumin	Union Carbide Corp.	CIX	Class II	1980-10-31
K802433	Bard Male External Catheter	C.R. Bard Inc	KNX	Class II	1980-10-31
K802427	La-Sporo Antibody System	IMMY, Inc.	GMA	Class I	1980-10-31
K802424	Ostomate Third Hand	Smith'S Ostomy Products, Inc.	EXB	Class I	1980-10-31
K802420	Centrifichem Inorganic Phosphorus	Union Carbide Corp.	CED	Class I	1980-10-31