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 2026-10-26, 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 2734 of 3530

510(k) clearances, page 2734 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880781	Datalogger Chart Recorder	Air-Shields, Inc.	DSF	Class I	1988-05-11
K880693	Medsurg Myelogram Tray	Medsurg Industries, Inc.	FMF	Class II	1988-05-11
K880685	Porcelite Dual Cure Cement	Kerr Corporation (Danbury)	EMA	Class II	1988-05-11
K880684	Xr Primer	Kerr Corporation (Danbury)	KLE	Class II	1988-05-11
K880663	Shiley Bcd Plus Heat Exchanger	Shiley, Inc.	DTR	Class II	1988-05-11
K880589	Rota-Dent Tooth Cleaner	Pro-Dentec	JEQ	Class I	1988-05-11
K880348	Palladium-Based Dental Alloys for Porcelain Appli.	J.F. Jelenko & Co., Inc.	EJT	Class II	1988-05-11
K880221	Incstar's Pigweed Allergen Disc	Incstar Corp.	DHB	Class II	1988-05-11
K880168	Incstar's Birch Allergen Disc	Incstar Corp.	DHB	Class II	1988-05-11
K875316	Bionica Mds 110 Pca	Bionica, Inc.	FRN	Class II	1988-05-11
K875251	Artis 3200 Diagnostic Ultrasound Device	Philips North America LLC	IYO	Class II	1988-05-11
K874883	Walnut Allergen Disc	Incstar Corp.	DHB	Class II	1988-05-11
K874861	Acuson S328 Transducer for Cardiac Color Flow App.	Acuson Computed Sonography	DPT	Class II	1988-05-11
K874590	Innovative Implants and Cover Screws	Implant Innovations International, Inc.	DZE	Class II	1988-05-11
K874546	Sim Module	Critikon Company, LLC	FRN	Class II	1988-05-11
K874540	Marsh Elder Allergen Disc	Incstar Corp.	DHB	Class II	1988-05-11
K880831	Large Lumen Y Adapter W/rotating Device	Interventional Medical, Inc.	DTL	Class II	1988-05-10
K880572	Ohmeda 2350 Finapres(r) Blood Pressure Monitor	GE Healthcare	DXN	Class II	1988-05-10
K875068	Aids Safety Belt	Aids Safety Belt, Inc.	HIS	Class II	1988-05-10
K874917	Python Ambulatory Blood Pressure Monitoring System	Oxford Medilog, Inc.	DXN	Class II	1988-05-10
K881618	Aseptex 1809 Fluid-Resistant Molded Surgical Mask	3M Company	FXX	Class II	1988-05-09
K880779	Medsurg 16 Ga. Central Vein Catheterization Tray	Medsurg Industries, Inc.	DWF	Class II	1988-05-09
K880715	(Mb-650) Blood Pressure Monitor	Sharp Electronics Corp.	DXN	Class II	1988-05-09
K881666	Hr(tm) Intravascular Catheter	Abbott Medical	FOZ	Class II	1988-05-06
K881510	Clp Abnormal Coagulation Control	Creative Laboratory Products, Inc.	GGC	Class II	1988-05-06
K881262	Caraway Tubes, Heparin and Plain	Helps Products, Inc.	GIO	Class I	1988-05-06
K881187	Natelson Tubes, Heparin and Plain	Helps Products, Inc.	GIO	Class I	1988-05-06
K880903	Bard (R) Eska Erectiometer	C.R. Bard Inc	LIL	Unclassified	1988-05-06
K880898	Multicor and Pacemakers	Tpl-Cordis, Inc.	DXY	Class III	1988-05-06
K880821	Resubmitted Abbott Testpack Rotavirus	Abbott Medical	LIQ	Class I	1988-05-06
K880712	Clp Normal Coagulation Control	Creative Laboratory Products, Inc.	GIZ	Class II	1988-05-06
K880698	Titan Gel-Pc Glyco-Heme(tm) System	Helena Laboratories, Corp.	LCP	Class II	1988-05-06
K880672	Sentinel Pulse Oximeter	Sentinel Monitoring Technologies, Ltd.	DQA	Class II	1988-05-06
K880671	Modified Intersept Pediatric Blood Filter	Medtronic Blood Systems, Inc.	DTM	Class II	1988-05-06
K880644	Ultra-Pan for Orthotic Plastics (7262)	Fred Sammons, Inc.	IRQ	Class I	1988-05-06
K880601	Wire Pass Drill Bits	Nuell Air Equipment & Hospital Supplies, Inc.	HBE	Class II	1988-05-06
K880595	Horizon 2000/S 266-Xxx-Xxx	Mennen Medical, Inc.	DPS	Class II	1988-05-06
K880554	Vsm(r) R2 Paper Chart Recorder	Physio Control, Inc.	DSF	Class I	1988-05-06
K880487	Neotech Meconium Aspirator (Sterile)	Neotech Products, LLC	BTR	Class II	1988-05-06
K880269	Lcs Femoral Hip Prosthesis	Depuy, Inc.	JDI	Class II	1988-05-06
K880196	Laminaria	Medgyn Products, Inc.	HDY	Class II	1988-05-06
K875159	Detectadot System 2000 Cmv Igg Test	Gull Laboratories, Inc.	GQI	Class II	1988-05-06
K874606	Cathra Gram Positive Screen	Mct Medical, Inc.	LQL	Class I	1988-05-06
K874127	Abbott Testpack Rsv	Abbott Medical	GQG	Class I	1988-05-06
K881762	Rolls 2000 Series Wheelchair	Invacare GmbH	IOR	Class I	1988-05-04
K881704	Easy TENS	American Imex	GZJ	Class II	1988-05-04
K881603	Ultra Traction	Component Equipment Mfg., Inc.	ITH	Class II	1988-05-04
K881598	Sdl Trichrome Stain	Scientific Device Laboratory, Inc.	JTS	Class I	1988-05-04
K881484	Biofragmentable Bowel Anastomosis Ring	Davis & Geck, Inc.	GDW	Class II	1988-05-04
K881460	Smokevac Electorsurgical Pencil	Byron Medical	GEI	Class II	1988-05-04